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4

Surgical procedures

Sunil Shah, Mohammad Laiquzzaman and Stephen J Doyle

Although the idea that the ocular power of the human eye could be changed to correct ametropia has been around since ancient times, the modern concepts of refractive surgery were devised in Europe during the early part of 19th century and developed to its modern status in Japan and Russia.1–3 These concepts were based on the idea that modification of the corneal curvature could alter the refractive power of the eye and thereby help millions of people to be able to see without any visual aids. Radial keratometry (RK) has played a critical role in the development of refractive surgery. RK opened the window to the surgical correction of common refractive disorders. However, the relative safety and efficacy of excimer laser refractive surgery has brought this new field into the realm of everyday practice and made refractive surgery acceptable to the general public as well as to the ophthalmic profession. As about one-quar- ter of the world’s population have refractive errors,4 the potential population for treatment is huge.

History

In the late 19th century, Lans showed experimentally that non-perforating radial incisions caused central corneal flattening accompanied by peripheral steepening.5 Greater central flattening was noted with deeper incisions. In the 1930s, Sato of Japan noted corneal flattening in several patients with keratoconus after spontaneous ruptures in Descemet’s membranes.6 Based on this concept, Sato performed RK in patients with keratoconus and successfully induced central corneal flattening.7 Enhanced flattening was achieved in the late 1940s by adding anterior radial incisions.7 Sato’s tech-

nique was modified by several Soviet ophthalmologists during the 1970s. They placed radial incisions in the anterior peripheral cornea only. Multifactorial formulas that incorporated patient and surgical variables were devised by Fyodorov to improve predictability.8,9 Millions of Americans underwent this procedure in the subsequent years. However, the procedure did not become popular in the UK or in many parts of Europe, which may, in part, be because in Europe excimer lasers were approved for refractive surgery many years before the Food and Drugs Administration (FDA) in the USA gave similar approval.

In 1983, Trokel et al. discovered a new form of tissue–laser interaction.10,11 Srinivasan, an engineer, was studying the far ultraviolet (193nm), argon fluoride (ARF) excimer laser for computer-chip photo-etching applications, when Trokel, an ophthalmologist, observed that corneal tissue could also be removed discretely and precisely with minimal damage to the adjacent corneal tissue. Trokel recognized the potential of the excimer laser to offer a new sculpting approach to corneal surgery.

Photoablation occurs because the cornea has an extremely high absorption coefficient at 193nm, such that the 193nm photon has sufficient energy to break directly carbon–carbon and carbon–nitrogen bonds that form the peptide backbone of the corneal collagen molecule. Consequently, excimer laser radiation ruptures the collagen polymer into small fragments and a dis-

crete volume of corneal tissue is removed with each pulse of the laser.12,13 The depth

of the ablation per pulse is dependent on the radiant exposure, typically within the range

0.1–0.5μm per pulse at a radiant exposure of 50–250mJ/cm2.14,15

Table 4.1 Currently available refractive procedures

Refractive keratotomy

Arcuate or astigmatic keratotomy (AK)

Photorefractive keratectomy (PRK) Laser epithelial keratectomy (LASEK) Laser in situ keratomileusis (LASIK) Intracorneal ring segment (ICRS) Corneal inlay lenses (CIL)

Phakic intraocular lenses (phakic IOL) Clear lens extraction (CLE)

Presbyopic surgery

During the early years, it was suggested that the excimer laser could be used as a ‘laser scalpel’ for corneal surgery in procedures such as RK.16 However, the excimer laser is a poor replacement for a cutting scalpel, because the laser removes tissue rather than incising it.17

The more promising application of the excimer laser is to re-shape the corneal curvature and thereby alter its refractive power.18 This new technique was termed

photorefractive keratectomy (PRK) by Marshall et al. and Liu et al.18,19 McDonald

et al. treated the first sighted human eye in 1989.20 The currently available refractive procedures are listed in Table 4.1.

Decision making for appropriate surgical procedures

About 25% of the adult Caucasian population are myopic and 90% of these are –6D or less. As a rough guide, most low myopes (less than –6D) achieve within 0.5D of the goal and most higher myopes

28 Refractive surgery: a guide to assessment and management

(–6 to –10D) achieve within 1D. Although surgery is less accurate for the higher myopes, the patients are often even more pleased, as they are effectively blind without glasses or contact lenses.

The end results of PRK and laser in situ keratomileusis (LASIK) are the same in low prescription ranges.21 It is expected that the results from laser epithelial keratectomy (LASEK) will be similar. LASIK ‘gets there’ faster and with less patient discomfort than PRK or LASEK, whereas PRK and LASEK are essentially safer. Which procedure to choose depends on each patient’s attitude to risk versus convenience. Neither procedure should be used for myopia greater than about –10 D, as the optical zones carved on the cornea are too small for low light vision. One eventually simply runs out of cornea! If the cornea is thicker than average, more treatment is possible and, correspondingly, if it is thinner then less is viable. LASIK is better for the high myopes because of the speed of visual recovery and predictability. There is an ‘overlap’ area between –2 to –3D for which the pros and cons are about even. LASEK is a recent modification of PRK and can be the treatment of choice for patients with high myopia and a thin steep cornea, and in patients for whom LASIK is contraindicated.22

Excimer laser technology

The term excimer comes from ‘excited dimer’ – a mixture of two inert gases that bind together to produce an unstable diatomic gas halide. The gases involved are from the halogen and noble gas groups. Krypton fluoride (KrF) lasers use an ultraviolet wavelength of 248nm and ArF lasers use an ultraviolet wavelength

of 193nm. Ultraviolet light is strongly absorbed by most biomaterials. At 193nm the laser-head photon energy is around 6.4 electron volts (eV), sufficient to break the corneal intermolecular bonds, which are about 3.6eV, without causing any thermal effects. The remaining energy is used to expel particles from the surface at supersonic speeds, but with no significant heating of the adjacent tissues. At wavelengths greater than 200nm, the thermal effects become more marked locally. Investigations of a range of excimer lasers have shown the ArF laser to produce the smoothest ablations of the corneal tissue, with minimal collateral damage from thermal diffusion. However, even at 248nm,

the photons still cannot penetrate more than a few microns.23,24

Treatment plan

Figure 4.1 gives a proposed plan for surgery favoured by the authors.

Individual surgical procedures

Refractive keratectomy and PRK are not discussed separately as the authors feel these are essentially outdated procedures.

PRK versus LASEK versus LASIK

Shah et al. carried out a prospective, nonrandomized, comparative, paired-eye trial that comprised 72 eyes of 36 patients, using a Nidek EC-5000 excimer laser.25 The eyes were divided into two groups. The first eye of each patient was treated with 20% ethanol debridement and the second eye with an epithelial flap, which was replaced after treatment. After a mean follow up of 62.6 weeks, the final mean

spherical equivalent (MSE) was +0.07 ± 0.61D in the debridement group and –0.24

± 0.43D in the epithelial flap group. There was no statistically significant difference between the two groups in the post-oper- ative MSE. The best-corrected visual acuity (BCVA) was better in the epithelial flap group at all visits, a difference that was statistically significant (p < 0.05). The corneal haze was less in the epithelial flap group, and again the difference was statistically significant (p < 0.05). In another study, Anderson et al. also found better and quicker post-operative results, and most patients achieved a better correction for myopia and myopic astigmatism than achieved with LASIK, quicker epithelial healing and no or fewer complaints of pain.26 Serrati concluded that LASEK may prove superior to LASIK.27 Shahinian reported no serious or vision-threatening complications with LASEK,22 for a wider range of patients and with the elimination of stromal flap complications.

LASEK

Indications, absolute contraindications and relative contraindications for LASEK are given in Table 4.2.

Overview

LASEK is a relatively new technique that combines particular advantages of LASIK and of PRK, and is slowly gaining popularity. The technique is safe, the epithelial healing is faster with reduced stromal haze, and it has quicker post-operative recovery and

minimum post-operative pain compared with PRK.22,25–29 The main rationale

behind LASEK is to keep the corneal epithelium alive to prevent biochemical changes in the cornea, which can lead to haze formation. It is inherently safer than LASIK and so patients are attracted to this treatment.

>+4.5

+4.5 to +1

+1 to –2

 

–2 to –3

–3 to –6

>–6

 

 

CLE

LASIK

LASEK

LASEK

LASIK

LASIK

Thick cornea,

Thin cornea

 

 

 

 

 

 

consider

 

unsuitable for LASIK

 

 

 

 

 

 

for LASIK

 

 

 

 

 

 

 

 

LASEK +

Phakic IOL

CLE

 

 

 

 

 

mitomycin 0.02%

>35 years

>35 years

Figure 4.1

Author’s treatment plan for an individual patient

Surgical procedure

The cornea is anaesthetized by topical anaesthetics. Usually, the non-operated eye is covered with an eye pad. The patient is made to lie on a couch and asked to focus on a flashing light. A lid speculum is inserted in the eye to be treated. A LASEK 8.0mm corneal trephine is used to create an epithelial incision. The circular blade is designed to perform a 270° incision with a blunt section at the 12 o’clock position for a hinge. A 9mm corneal ring is applied, which acts as a cup and is filled with 18% ethanol and left for 30 seconds. This 9mm corneal ring allows a 7.5mm treatment zone to be achieved, as the epithelium at the edges is still adherent. A flap can be raised in most eyes 20–25 seconds after the application of ethanol, but in some patients the epithelium is more adherent and needs more time. The ethanol is soaked up with a mercel sponge and the cornea washed with a topical nonsteroidal anti-inflammatory agent applied (diclofenac). An epithelial flap is fashioned by lifting (not debriding and not damaging the stromal bed) the edge of the loosened epithelium with a sharp beaver blade. The flap can be created horizontally or vertically, or the epithelium is cut in the centre and a flap is created in all four directions. Once the epithelial flap has been created, the

Table 4.2 Indications, absolute contraindications and relative contraindications for LASEK

Indications

Age 21 years and above Stable refraction

Adequate central corneal thickness Myopia –3.00D to –6.00D Hyperopia up to +4.00D Astigmatism up to 4.00D

Absolute contraindications

Keratoconus

Herpes virus infection of the cornea Deep corneal dystrophy

Grossly amblyopic eye Corneal melt Unstable refraction

Relative contraindications

Significant cataract

Certain occupations (pilots, computer programmers and heavy goods vehicle drivers, because contrast sensitivity and glare can be a handicap among these groups of patients)

Patients with obsessive personality

corneal stroma is bare and laser is applied without delay, before the stroma dehydrates, as this might lead to overcorrection. The patient must be warned that the ablation usually produces a burning smell.

After laser ablation the flap is replaced onto the cornea. A contact lens is then placed on the eye and removed after 4 days. This results in less pain and quicker visual recovery than for standard PRK. This procedure is especially beneficial for patients with small palpebral apertures, deep-set eyes, extremely flat or steep corneas, thin corneas or high myopia, as well as for patients who may not qualify for refractive surgery.28

Post-operative care

Post-operative care includes topical antibiotics for 1 week. The patients are told to avoid swimming, contact sports, dust and smoke for about a month. Reviews of the patients are usually after 1 week, 6 weeks and 6 months. The vision gradually improves over a few days to a few weeks (at most) depending on the size of the ablation.

Complications of LASEK

As LASEK and PRK are essentially same procedures, the potential complications are the same.26 However, in the authors’ experience since using this technique, the incidence of complications is very low. The authors have not seen haze that affects visual acuity. The complications after LASEK can be classified into two broad groups:

Refractive; and

Miscellaneous.

These are summarized in Table 4.3.

Table 4.3 Complications after

LASEK

Intra-operative

Intra-operative loss of epithelial flap25

Refractive

Early:

Induced irregular astigmatism

Primary undercorrection

Primary overcorrection

Late:

Regression

Undercorrection

Overcorrection

Miscellaneous

Decentred ablation

Glare

Haloes

Ptosis

Infectious keratitis

Surgical procedures 29

LASIK

Overview

LASIK was first performed by Pallikaris et al. in 1990,30 and is a combination of excimer laser with lamellar corneal surgery for the correction of refractive errors. LASIK is mainly carried out to correct myopia, but it is also used to correct astigmatism and hyperopia. Most refractive surgery in the USA is now LASIK. To achieve the desired refractive power the corneal thickness and shape are altered. The excimer laser is used to ablate the corneal stromal tissue to achieve the desired refractive change.30,31

Indications, absolute contraindications and relative contraindications for LASIK are given in Table 4.4.

Surgical procedure

The patient lies on a couch with the excimer laser delivery system above the patient’s head. The cornea of the eye to be operated is anaesthetized with topical anaesthetic drops.

A lid speculum is inserted after instilling topical anaesthesia. The patient is asked to fixate on the laser bream and the cornea is marked with gentian violet to help realign the flap. A suction ring is applied to the limbus and the pressure increased to more than 65mmHg to

Table 4.4 Indications, absolute contraindications and relative contraindications for LASIK

Indications

Stable refraction (no change over a period of 2 years)

Age ≥21 years

Adequate central corneal thickness Myopia ≤–10.00D

Hyperopia ≤+4.00 to 5.00D Astigmatism ≤6D

Absolute contraindications

Keratoconus

Central corneal thickness <410μm Unstable refraction

Deep corneal dystrophy

Previous corneal melt (or systemic conditions predisposing to corneal melt)

History of herpetic keratitis Amblyopia

Relative contraindications

Cataract

Selected occupations (e.g., commercial pilots)

Obsessive personality

30 Refractive surgery: a guide to assessment and management

ensure a regular cut. This is confirmed using an applanation tonometer. The patient may feel a transient loss of vision because of increased intraocular pressure. An automated microkeratome is fitted on the track and activated to pass across the cornea to create stromal flap. The vacuum is released and the epithelial flap is reflected back to expose the stromal bed. The hinge of the flap is made, either nasally or at the 12 o’clock position. Pachymetry is repeated to ensure adequate residual tissue, and excimer laser ablation is carried out on the corneal stroma. The patients are warned that they might experience a pungent smell during laser ablation. The ablation usually takes less than 90 seconds. The flap is washed with balanced salt solution and replaced. Centration is checked and the edges are smoothed down. After checking the adhesion, the speculum is removed. Topical antibiotics and topical corticosteroid are prescribed for 1 week.

Post-operative care

The patient is directed to avoid swimming, dust or smoke and any contact sport for about 1 month after the surgery. A clear eye shield is worn during sleep for 2 weeks to avoid trauma while sleeping. The patient is examined after 1 day, 1 week, 1 month, 3 months, 6 months and 1 year.

Complications

Complications of LASIK can be divided into two broad groups, intra-operative and post-operative, which can be further subdivided as early and late.

Flap related complications

The intra-operative flap complications include incomplete or free (completely cut) flap, lost flap, decentred flap, irregular flap and flap stria.32 However, Jacobs and Taravella, in a study on 84,711 eyes, conclude that overall flap complications are very low (0.3%).33

Late complications are epithelial ingrowth (epithelium within the stromal interface, one of the most common causes of reduced visual acuity),32 wrinkles or

striae, interface infection and flap dislocations.34,35

Refractive complications

These include underor overcorrection, regression, decentred ablation and induced irregular astigmatism caused by folds or microstriae of flaps.32 This is often difficult to correct and results in decrease in visual acuity and/or quality of vision. Other complications are given in Table 4.5.

Clinical outcomes

LASEK

Predictability

Claringbold conducted a study in 222 eyes with myopia that ranged from –1.25 to –11.25D and astigmatism up to 2.25D.29 Of these, 84 eyes had a 1 year follow-up, of which 82.0% had an uncorrected visual acuity (UCVA) of 20/20 or better and 100% had an UCVA of 20/25 or better.

In another study, 343 eyes with refractive errors that ranged from –1.00 to –14.00D and astigmatism up to +4.75D were followed up for 6 months. Of these patients, 98% had unaided visual acuity of 20/40 or better.26 Shahinian reported, in a study of 146 eyes with myopia that ranged from –1.00 to –14.38D, that the UCVA was 20/40 or better in 96% of the eyes after a 12 month follow-up.22

Stability

O’Bart, in a study on 105 eyes, reported that refractive stability was rapid with a mean refractive change between 1 week and 6 months post-operatively of ±0.34D.37 Claringbold reported that all eyes achieved ±0.75D of the intended correction and more than 96% of the eyes were within ±0.5D after 12 months.29

Loss of uncorrected visual acuity

In a study of 222 eyes with myopia that ranged from –1.25 to –11.5D, UCVA was 20/40 or better after 4 days in more than 80% and 20/20 or better in 75% after 2 weeks.29

Loss of best-corrected visual acuity

Claringbold in a study on 222 eyes reported no loss of BCVA.29

Table 4.5 Non-refractive complications after LASIK

Central islands36 Interface debris32 Haze

Glare and haloes34 Infectious keratitis (rare)32,34

Diffuse interstitial keratitis (sands of Sahara)32

Dry eye34 Endothelial cell loss34

Night-vision problems36 Reduction in corneal sensitivity34 Posterior ectasia29

LASIK for myopia

Predictability

Pop and Payette reported a study of 107 LASIK-treated myopic eyes with refractive error that ranged from –1.00D to –9.00D.21 Of these eyes, 70% (77 eyes) were evaluated 12 months post-opera- tively, of which 100% had UCVA of 20/40 or better and 83% achieved UCVA of 20/20 or better. In another study of 290 highly myopic eyes (range from –9.00 to –22.00D), the UCVA was 20/40 or better in 73.3% after 1 month.38

Stability

In 131 eyes with high myopia (range from –9.00 to –22.00D), overall most scores were stable or improved between early and late follow-ups. In 88% of the eyes, UCVA was stable or improved after 1 month and in 95% of the eyes BCVA was stable or improved after 1 month.38

Loss of best-corrected visual acuity

Pop and Payette reported that after 1 month of surgery 90% of the eyes were within ±1.00D and 64% of the eyes were within ±0.5D of BCVA.21 After 12 months, 99% were within ±1.00D and 78% were within ±0.5D. No eye lost two Snellen lines of BCVA.

LASIK for hyperopia

Predictability

LASIK can be used reasonably successfully to treat low hyperopia. Cobo-Soriano et al. conducted a study of 376 hyperopic eyes (range from +1.00D to +8.50D), for which a mean post-operative refraction of +0.46 ± 0.8D was achieved after a follow up of 8.2 months.39 In eyes with an error of +4.00D, the final UCVA was 20/40 in 96%, and 88% in patients with >+4.00D.

In another study on 54 hyperopic eyes (range +1.00D to +6.00D), Lian et al. reported that predictability was good after 12 months: 83% eyes were within +1.00D and 66% achieved +0.5D.40

Loss of uncorrected visual acuity

Lian et al. also reported that 92.6% of the eyes had UCVA of 20/40 or better and 63% had 20/20 or better.40 One eye lost two lines of BCVA and two eyes gained two or more lines.

LASIK versus LASEK

This topic is covered in more detail in Chapter 8, but here it is sufficient to say that in some prescription groups the end results of LASIK and LASIK are the similar. Claringbold suggests that LASEK appears to be safe and more effective than

LASIK in that complications related to the stromal flap are eliminated and it can be performed in patients for whom LASIK may be contraindicated (e.g., deep-set eyes, thin corneas, etc.).29 However, LASEK has some disadvantages with respect to LASIK:

Patients experience varying degrees of pain during the first 2 days after surgery;

Recovery of vision is slower, as vision is somewhat blurred for the first week after LASEK surgery; and

Patients may have mild recurrent epithelial erosion and so require postoperative corticosteroid for a longer period than required after LASIK.

Intracorneal ring segments

Overview

Intracorneal ring segments (ICRS) is a procedure based on the assumption that the refractive error can be corrected by flattening the cornea using tissue added to the outer two-thirds of cornea. This extra tissue in the peripheral cornea distends the cornea, which in turn flattens the central cornea.41

This technique is used to correct low myopia and astigmatism. In this procedure half-ring segments of Perspex are inserted into channels created in the corneal stroma, which results in a flattening of cornea. The advantage is that the central cornea is not involved and the ring is positioned outside the pupillary margin. This process is easily reversible and the corneal shape remains intact.

The indications for ICRS are low grade myopia <4.5D and keratoconus.

Surgical procedure

The operation is carried out under sterile conditions. The geometrical centre of the cornea is marked and intra-operative ultrasonic pachymetry carried out at the sight of incision. The diamond blade is set at 70% of the measured corneal thickness to create a single radial incision that is less than 2.0mm at the steepest meridian. A stromal pocket is dissected on both sides of the incision using a modified spatula. The intrastromal dissection is created to the full depth of the incision. Either a suction device is used to dissect a stromal plane to create semicircular lamellar pockets or this can be carried out manually.42 After removal of the suction device, two intracorneal rings of different thicknesses are inserted into each semicircular channel. Selection of the rings is based on the refractive error. Finally, the radial incision is sutured with nylon sutures. Post-opera- tive antibiotics and hydrocortisone are

given to minimize the risk of keratitis. The advantages and disadvantages are given in Table 4.6, but the procedure is not popular among UK surgeons,

Holmium laser thermokeratoplasty and diode thermokeratoplasty

Holmium laser thermokeratoplasty (LTK) and diode thermokeratoplasty (DTK) are used to correct hypermetropia. In both of these procedures an infra-red laser is used to coagulate the cornea. Spots are arranged in a ring 6–9mm from the centre of cornea, and as the scar tissue forms the central cornea steepens. Charpentier et al. reported that the stability of refractive outcome is poor.44

Phakic intraocular lenses

Overview

The word ‘phakic’ is derived from the Greek phakos, which means lens. Phakic intraocular lenses (PIOLs) are artificial lenses placed inside the eye to correct refractive error such as myopia and hyperopia. For years, intraocular lenses (IOLs) have been used during cataract surgery after removal of the natural crystalline lens. More recently, IOLs were designed to be placed in the eye to correct refractive error without removal of the natural lens. Additional IOLs are used to treat refractive errors. This surgical procedure is generally carried out to treat high refractive errors for which corneal surgery cannot be performed. In this technique, lenses made of polymethylmethacrylate or colorate (which is a soft lens made of collagen, water and polymers) are placed inside the eye. The lens is wedged between the posterior surface of the cornea and the anterior surface of the iris, or is attached to the

Table 4.6 Advantages and disadvantages of intracorneal ring segments

Advantages

Corneal shape is not disturbed Centre of the cornea is not touched Process is reversible

Surgical procedure is safe Adjustment can be performed using thinner or thicker rings41

Useful in keratoconus eyes

Predictability of surgical outcome is good44

Disadvantage

Can only be used in low myopia (e.g., <4.50D)

Surgical procedures 31

anterior surface of the iris by a clip, or is placed in the space between the posterior surface of the iris and the anterior surface of the natural lens of the eye.

The indications are:

Myopia >–5.00D;45

Hyperopia >+5.00 to +15.00D;45

Thin corneas;

Previous refractive keratotomy surgery.

Surgical procedures

Anterior chamber lens implantation

The surgery is carried out under sterile conditions to avoid intraocular infection. The pupil is dilated with mydriatics and anaesthesia, either topically or with peribulbar anaesthetics. A temporal corneal incision of about 3–3.5mm is made with the diamond blade. Sodium hyaluronate is injected into the anterior chamber to deepen it. The lens is implanted into the anterior chamber, the haptic ends are placed under the iris with a spatula and the lens is centred. Peripheral iridectomy is performed to avoid blockage by the peripheral haptic. The viscoelastic material is removed by either irrigation or aspiration with balanced solution. Postoperative antibiotic and corticosteroid drops are given for 5–7 days.

Posterior chamber lens implantation

The pupil is dilated with mydriatics and the eye to be treated is anaesthetized with peribulbar anaesthetics. A temporal or nasal corneal incision of about 3–3.5mm is made with the diamond blade. The silicone IOL is implanted in front of the natural crystalline lens, under the protection of a viscoelastic substance. No suture is necessary. A peripheral iridectomy is performed, either intra-operatively or by laser after surgery. At the end of the surgical procedure, gentamicin and corticosteroid are given topically or both topically and subconjunctivally.

The advantages and disadvantages of PIOL procedures are given in Table 4.7.

Surgical outcome, anterior chamber lens implant

Loss of best-corrected visual acuity

Hoyos et al. reported for anterior chamber lens implantation a mean BCVA in myopic eyes of 20/35 and in hyperopic eyes of 20/23 after 1 year in a study on 31 eyes (17 myopic and 14 hyperopic, myopia ranged from –11.8 to –26.00D and hyperopia from +5.25 to +11.00D).45 In myopic eyes, no eye lost lines of acuity, and in hyperopic eyes one eye gained one line of BCVA and one eye lost one line.

32 Refractive surgery: a guide to assessment and management

Table 4.7 Advantages and complications of phakic intraocular lenses

Advantages

Preservation of accommodation Compatibility with proved cataract and

phakic IOL implantation procedures Correction of higher levels of myopic

and hyperopic refractive errors Reversibility46–48

Complications

Post-surgical astigmatism Secondary glaucoma (major

complication of the anterior chamber lens)

Chronic intraocular inflammation Pigment dispersion

Uveitis

Endothelial cell damage Cataract formation Endophthalmitis

Glare and poor-quality vision at night with a wider pupil

Predictability

After 1 year follow-up, the MSE of refraction was –0.22 ± 0.87D in myopic eyes, with 87% within the desired refraction of ±1.00D; in hyperopic eyes the MSE was +0.38 ± 0.82D, with 79% within the desired refraction of ±1.00D.45

Surgical outcome, posterior chamber lens implant

Loss of best-corrected visual acuity

Brauweiler et al. evaluated 18 eyes with high myopia (pre-operative MSE –14.58 ± 3.04D).49 BCVA remained unchanged in one eye or improved by two lines or better, and three eyes lost one line of BCVA.

Predictability

After 2 years follow-up the MSE was –1.33

± 0.71D.

Clear lens extraction

Overview

Various treatments for patients with high refractive errors have been used in the past (e.g., glass spectacles, contact lenses, etc.), but the higher the refractive error the higher the dissatisfaction with these traditional treatment methods. During the past two decades refractive surgery has made much progress and become popular. More and more patients with refractive error seek life without these traditional

methods of treatment (e.g., glass and contact lenses), and refractive surgery results are promising in terms of rapid recovery and safety.29

The indications are:

High myopia >6.00D; and

Hyperopia.

Surgical procedure

This surgical procedure is similar to a cataract operation, the only difference being that the natural crystalline lens is removed even though it is not opaque, and an artificial lens is implanted. The IOL’s strength is calculated such that when it replaces the crystalline natural lens the required refractive power is achieved.

The complications of clear lens extraction are given in Table 4.8.

Results

Loss of best-corrected visual acuity

Usitalo et al. reported that, for 38 eyes, 71.9% gained one or more lines and 40.6% gained two or more lines in their study of highly myopic eyes (range from –7.75D to –29.00D), and 6.2% lost one line of BCVA after 1 year.50

Accuracy

In the same 38 eyes, the spherical equivalent refraction was within ±1.00D in 81.6% and within ±0.5D in 71.1%, and in eyes with myopia <–18.0D refraction of within ±1.00D was achieved in 96.4% and within ±0.5D in 85.7%.50

In another study by Pop et al. of 65 eyes with hyperopia up to +12.25D, 1 month after clear lens extraction the BCVA was

20/40 or better in 95% of eyes and 20/20 or better in 38.5%.51

Long-term safety

The short-term results are very promising, and long-term safety is as for cataract surgery.

Presbyopic surgery

Overview

Accommodation is the mechanism by which the curvature of the anterior surface of a crystalline lens increases, and it produces the optical power of the lens.52 In a relaxed state the suspensory ligament, which is attached to the lens and ciliary muscle, is in tension and so stretches the lens and keeps it flatter. However, during accommodation the ciliary muscle contracts, which in turn reduces the tension of the suspensory ligament and allows the anterior surface of the lens to move towards the cornea. The change in the curvature of lens

Table 4.8 Complications of clear lens extraction

Post-surgical astigmatism Chronic intraocular inflammation Posterior capsular opacity Endothelial cell damage

Uveitis Endophthalmitis Glare

occurs in the centre, and the peripheral part flattens. With advancing age the lens material reduces or loses its elasticity, which results in a reduction or loss of forwards movement of the lens and finally in loss of accommodation. This condition is known as presbyopia.

Surgery for presbyopia is in its infancy. It can be either corneal, scleral or an IOL implant using a multifocal or accommodative lens. The lens is implanted after cataract surgery, on the assumption that movement of the vitreous gel behind the lens will create the desired refraction.53

Surgical procedure

Corneal surgery

A multifocal cornea is created under a LASIK flap by steepening the cornea inferior or by implanting a multifocal intracorneal inlay.

Scleral surgery

Scleral surgery can be carried out by surgical incision or laser. The required result is expected to be achieved by creating a multifocal cornea.

Intraocular

An intraocular procedure was first described in 1997, and is called presbyopic lens exchange (PRELEX).53 IOLs are used to restore accommodation at the time of cataract surgery.52 Two types of lenses are used mainly:

Accommodative lenses are singlepower optic lenses. The theory is that this will mimic the natural physiology of the eye, whereby relaxation and contraction of the ciliary muscle will result in a change in the power of the lens.

Multifocal lenses comprise two main types, refractive and defractive multi-

focal IOLs. Use of these lenses to treat presbyopia has been approved by the FDA.

The complications of presbyopic surgery are given in Table 4.9.

Table 4.9 Complications of presbyopic surgery

Dislocation of lens Long-term refractive stability Lens decentration

Fibrosis of the lens capsule that resultsin loss of forwards movement of the implanted lens

Glare

Haloes

Post-operative refractive errors Surgically induced astigmatism

Surgical outcome

A study carried out on 456 patients treated with bilateral multifocal lens implantation reported 81% could function without glasses.52

Arcuate surgery

Arcuate keratotomy can be used to treat corneal astigmatism before and after cataract surgery. Several nomograms are available for the incisional keratotomy to

Surgical procedures 33

correct naturally occurring astigmatism. However, this is not the case for eyes with secondary astigmatism. Oshika et al. designed a prospective, multicentre study that involved 104 pseudophakic eyes with a corneal astigmatism of 1.50D or more.54 All these patients were treated with arcuate keratotomy incisions. The parameter of predictability (35%) was lower than that

reported for congenital astigmatism (56%).54

References

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Amano S and Shimizu K (1995).

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Akiyama K, Shibata H, Kanal A, et al.

 

Excimer laser photorefractive

 

(1992). Development of radial

 

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keratotomy in Japan, 1939–1960. In

 

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Refractive Keratotomy for Myopia and

 

S253–S260.

 

Astigmatism, p. 179–220, Ed. Waring GO

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Krueger RR, Trokel SL and Schubert HD

 

III. (St Louis: Mosby–Yearbook Inc).

 

(1985). Interaction of ultraviolet laser

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Schimmelpfennig BH and Waring GO

 

light with the cornea. Invest Ophthalmol

 

(1992). Development of refractive

 

Vis Sci. 26, 1455–1464.

 

keratotomy in the nineteenth century. In

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Cotliar AM, Schubert HD, Mandel ER

 

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and Trokel SL (1985). Excimer laser

 

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Waring GO (1992). Development of

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Marshall J, Trokel SL, Rothery S and

 

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Schubert H (1985). An ultrastructural

 

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(1986). Photoablative reprofiling of the

 

Rowland M (1983). Prevalence of

 

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laser–photorefractive keratectomy. Lasers

 

Ophthalmol. 101, 405–407.

 

Ophthalmol. 1, 21–48.

5

Lans W (1898). Experimentelle

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Andrade HA (1990). Myopic excimer

 

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corneawunden. Graefes Arch Clin Exp

 

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Sato T (1939). Treatment of conical

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McDonald MB, Kaufman HE and Frank

 

cornea (incision of Descemet’s membrane).

 

JM (1989). Excimer laser ablation in the

 

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human eye. Arch Ophthalmol. 107,

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Sato T, Akiyama K and Shimbata H

 

641–642.

 

(1953). A new surgical approach to

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myopia. Am J Ophthalmol. 36, 823–829.

 

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Fyodorov SN and Durnev VV (1979).

 

in-situ keratomileusis: A control-

 

Operation of dosaged dissection of

 

matched study. Ophthalmology 107,

 

corneal circular ligament in cases of

 

251–257.

 

myopia of mild degree. Ann Ophthalmol.

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Shahinian L (2002). Laser-assisted

 

11, 1885–1890.

 

subepithelial keratectomy for low to high

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Enaliev FS (1978). Experience in

 

myopia and astigmatism. J Cataract

 

surgical treatment of myopia. Vestn

 

Refract Surg. 28, 1334–1342.

 

Oftalmol. 3, 52–55.

23

Dagenhardt AH (1976). Light

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Trokel SL, Srinivasan R and Braren B

 

coagulation of the eye. Br J Physiol Opt.

 

(1983). Excimer laser surgery of the

 

31, 11–18.

 

cornea. Am J Ophthalmol. 96, 710–715.

24

Kerr-Muir MG, Trokel SL, Marshall J and

11

Srinivasan R (1986). Ablation of

 

Rothery S (1987). Ultrastructural

 

polymers and biological tissue by

 

comparison of conventional surgical and

 

ultraviolet lasers. Science 234, 559–565.

 

argon fluoride excimer laser keratectomy.

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Puliafito CA, Wong K and Steinert RF

 

Am J Ophthalmol. 103, 448–453.

 

(1987). Quantitative and ultrastructural

25

Shah S, Sarhan AS, Doyle SJ, Pillai CT

 

studies of excimer laser ablation of the

 

and Dua HS (2001). The epithelial flap

 

cornea at 193 and 248nm. Lasers Surg

 

for photorefractive keratectomy. Br J

 

Med. 7, 155–159.

 

Ophthalmol. 85, 393–396.

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Srinivasan R and Sutcliffe E (1987).

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Anderson NJ, Beran RF and Schneider

 

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TL (2002). Epi-LASEK for the correction

 

ablation of corneal tissue. Am J

 

of myopia and myopic astigmatism. J

 

Ophthalmol. 103, 470–471.

 

Cataract Refract Surg. 28, 1343–1347.

27Scerrati E (2001). Laser in situ keratomileusis versus laser epithelial keratomileusis (LASIK vs LASEK). J Refract Surg. 17, S219–S221.

28Dastjerdi MH and Soong HK (2002). LASEK (laser subepithelial keratomileusis). Curr Opin Ophthalmol.

13, 261–263.

29Claringbold II TV (2002). Laser assisted subepithelial keratectomy for the correction of myopia. J Cataract Refract Surg. 28, 18–22.

30Pallikaris IG, Papatzanaki ME, Siganos DS and Tsillimbaris MK (1991). A corneal flap technique for laser in situ keratomileusis. Human study. Arch Ophthalmol. 109, 1699–1702.

31Burrato I and Ferrari M (1992). Excimer laser intrastromal keratomileusis; Case reports. J Cataract Refract Surg. 18, 37–41.

32Stephenson C (2002). Complications of PRK, LASIK and LASEK: Diagnosis and treatment. Refract Eye News 1, 6–11.

33Jacobs JM and Taravella MJ (2002). Incidence of intra-operative flap complications in laser in-situ keratomileusis. J Cataract Refract Surg.

28, 23–28.

34Oliveira-Soto L and Charman WN (2002). Some possible longer-term ocular changes following excimer laser refractive surgery. Ophthalmic Physiol Opt. 22, 274–288.

35Sachdev N, McGhee CN, Craig JP, Weed KH and McGhee JJ (2002). Epithelial defect, diffuse lamellar keratitis, and epithelial ingrowth following post-LASIK epithelial toxicity. J Cataract Refract Surg.

28, 1463–1466.

36Farah SG, Azar DT, Gurdal C and Wong J (1998). Laser in situ keratomileusis: Literature review of a developing technique. J Cataract Refract Surg. 24, 989–1006.

37O’Bart D (2002). Laser epithelial keratomileusis (LASEK). Refract Eye News 1, 12–15.

38Kawesch GM and Kezirian GM (2000). Laser in situ keratomileusis for high myopia with VISX star laser.

Ophthalmology 107, 653–661.

39Cobo-Soriano R, Llovet F, González-Lopez F, Domingo B, Gomez-Sanz F and Baviera J (2002). Factors that influence outcomes of hyperopic laser in situ keratomileusis. J Cataract Refract Surg.

28, 1530–1538.

34 Refractive surgery: a guide to assessment and management

40Lian J, Ye W, Zhou D and Wang K (2002). Laser in situ keratomileusis for correction of hyperopia and hyperopic astigmatism with the Technolas 117C. J Refract Surg. 18, 435–438.

41Alio JL, Salem TF, Artola A and Osman AA (2002). Intracorneal rings to correct corneal ectasia after laser in situ keratomileusis. J Cataract Refract Surg.

28, 1568–1574.

42Siganos D, Ferrara P, Chatzinikolas K, Bessis N and Papastergiou G (2002). Ferrara intrastromal corneal rings for the correction of keratoconus. J Cataract Refract Surg. 28, 1947–1951.

43Asbell PA and Ucakhan OO (2001). Long term follow up of Intacs from a single center. J Cataract Refract Surg. 27, 1456–1468.

44Charpentier DY, Nguyenkhoa JL, Duplessix M, Colin J and Denis P (1995). Intrastromal thermokeratoplasty for correction of spherical hyperopia – one year

prospective-study. J Fr Ophtalmol. 18, 200–206.

45Hoyos JE, Dementiev DD, Cigales M, Hoyos-Chacon J and Hoffer KJ (2002). Phakic refractive lens experience in Spain. J Cataract Refract Surg. 28, 1939–1946.

46Baikoff G, Arne JL, Bokobza Y et al. (1998). Angle-fixated anterior chamber phakic intraocular lens for myopia of –7 to –19 diopters. J Refract Surg. 14, 282–293.

47Rosen E and Gore C (1998). Staar Collamer posterior chamber phakic intraocular lens to correct myopia and hyperopia. J Cataract Refract Surg. 24, 596–606.

48Landesz M, Worst JGF, Siertsema JV and van Rij G (1995). Correction of high myopia with the Worst claw intraocular lens. J Refract Surg. 11, 16–25.

49Brauweiler PH, Wehler T and Busin M (1999). High incidence of cataract formation after implantation of a silicone posterior chamber lens in

phakic, highly myopic eyes.

Ophthalmology 106, 1651–1655.

50Uusitalo RJ, Aine E, Sen NH and Laatikainen L (2002). Implantable contact lens for high myopia. J Cataract Refract Surg. 28, 29–36.

51Pop M, Payette Y and Amyot M (2001). Clear lens extraction with intraocular lens followed by photorefractive keratectomy or laser in situ keratomileusis. Ophthalmology 108, 104–111.

52Hope-Ross M. (2002). Lens surgery and presbyopia: Refract Eye News 1, 11–18.

53Chisholm C (2002). Report on the Current Status of Refractive Surgery. (Birmingham: British Society of Refractive Surgery).

54Oshika T, Shimazaki J, Yoshitomi F et al. (1998). Arcuate keratotomy to treat corneal astigmatism after cataract surgery: A prospective evaluation of predictability and effectiveness.

Ophthalmology 105, 2012–2016.

5 Post-operative follow-up of the

refractive surgery patient

Catharine Chisholm

Patients who have undergone any form of refractive surgery procedure require careful follow-up, particularly during the first year. In some clinics the operating surgeon undertakes all such examinations, but it is increasing likely that optometrists will be called upon to share the ever-increasing workload. The optometrist may be involved merely in refraction and topography measurements, or may have to undertake the full examination, particularly in cases for which the surgeon is not on site. Opinions vary considerably as to the point at which care of a patient can be passed from the surgeon to an optometrist, although 3 months appears to be a common handover point to general optometrists who do not specialize in postrefractive surgery patient care. It is important to clarify with whom the responsibility for the patient lies – this will vary depending on the co-management set up, which is discussed in Chapter 7. If time permitted, many surgeons would prefer to see the patient right up until the point of discharge to maintain continuity of care and collect outcome data. This allows surgeons to audit their own performance and modify their techniques accordingly. For this reason, it is important that optometrists involved in the assessment of refractive surgery patients provide feedback after each assessment, which should include details such as residual refractive error, uncorrected and best-correction vision, slit-lamp findings, symptoms, etc. The surgeon or a designated ophthalmological colleague must be contactable at all times in case problems are detected during a followup examination. Referral to the Hospital Eye Service should remain the last resort.

Once the refractive error and topography have stabilized, the cornea is quiet and any visual problems have been dealt with, the patient can be discharged back to their

own optometrist with a letter that provides details of the surgery and outcome. Optometrists involved in refractive surgery co-management are responsible for educating the patients on the importance of regular eye examinations. Patients will still need reading glasses when they reach presbyopia and the health of their eyes should be checked at least every 2 years, as for any other patient. Occasionally, non-presbyopic patients require a small residual correction for certain critical tasks, which again can be provided by the optometrist.

Initial post-operative period

The primary purpose of follow-up examinations during the early post-operative period is to recognize and manage acute problems, such as infections, slipped corneal flaps, etc. Over the longer term, examinations should include the investigation of refractive and topographical stability, address any visual problems and refer patients back for enhancements where necessary. Table 5.1 summarizes time scales for follow-up examinations.

Table 5.1 Suggested time scale for follow-up examinations

Follow-up time

Personnel

Primary purpose

Immediately

Surgeon

Check flap position and integrity

post-operative

 

(LASIK and LASEK)

 

 

 

1 week

Surgeon and

Check flap (LASIK and LASEK);

 

optometrist

check for epithelial closure (PRK)

 

 

 

1 month

Surgeon and

Look for epithelial ingrowth (LASIK)

 

optometrist

Haze maximum after PRK

 

 

Assess initial refractive outcome

 

 

 

3 months

Optometrist

Full examination

 

(and surgeon?)

Consider enhancement post-LASIK if

 

 

required and refraction stable

 

 

 

6 months

Optometrist

Full examination

 

(and surgeon?)

Consider enhancement post-PRK if stable

 

 

 

12 months

Optometrist

Full examination

 

(and surgeon?)

Discharge to general optometric practice if no

 

 

problems

 

 

Information letter to patient’s own optometrist

36 Refractive surgery: a guide to assessment and management

Photorefractive keratectomy

Some degree of aqueous flare is present in a large proportion of eyes during the first 24–48 hours.1 Patients can suffer quite severe pain and photophobia caused by the large epithelial wound and will need to use systemic painkillers during the first 24 hours, in addition to topical medication [antibiotics and non-steroidal antiinflammatory drugs (NSAIDs)]. Bandage contact lenses can be fitted to manage pain, but are rarely used after photorefractive keratectomy (PRK).

At 1 week

Re-epithelialization occurs within 4.6 ± 0.2 days of PRK (range 3–6 days).2 Epithelial cells from the margin of the wound migrate and proliferate to form a single layer of cells across the central cornea. Once this stage has been completed, mitosis gradually increases the number of layers to form a stratified epithelium. Functional vision returns upon re-epithe- lialization, with 83% of low myopes (–1.00 to –5.99D) achieving an unaided vision of 6/12 by 1 week.3 The initial refraction tends to be slightly hyperopic followed by a gradual drift towards emmetropia or myopia. Irregularities of both the refraction and topography are common at this stage. A significant epithelial defect is visible without fluorescein staining, but if this has to be used the eye should be irrigated thoroughly afterwards to remove any remaining dye. Slow re-epithelializa- tion tends to be associated with greater haze and regression in the longer term. By 1 week, there should be no pain, although mild grittiness may persist. If corticosteroids have been prescribed and the epithelium is intact, careful tonometry can be undertaken to detect steroid responders.

At 1 month

Subepithelial haze develops during the first month, and reaches a peak in intensity between 6 and 12 weeks.4,5 The formation of haze is a process of tissue remodelling that involves corneal basal epithelial cells,

activated keratocytes and the deposition of type III collagen within the stroma.6 Haze is visible because the cornea both reflects and scatters light back towards the observer. Haze should be graded as shown in Table 5.2. Grade 0.5–1.5 haze is not uncommon at 1 month and may be associated with a reduction in low-contrast acuity. Haze does not influence Snellen acuity unless it reaches grade 2 or more, but it can affect post-operative Orbscan data corneal thickness measurements should be interpreted with caution in the presence of significant haze.8

At 3 months

There should be little if any stromal haze by 3 months and best-corrected visual acuity (BCVA) should have returned to pre-operative levels. The refractive error should have regressed from low hyperopia to near emmetropia and some individuals may even show signs of refractive and topographical stability. If significant myopic regression is going to occur, it is generally evident by 3 months post-PRK.

At 6 months and beyond

Since PRK is now reserved for treatments of –4.00D or less, refractive stability is generally achieved within 6 months of surgery. Cellular activity ceases at around 3 months, but long-term healing processes continue for up to 18 months post-opera- tively. The time course of this activity correlates with an initial reduction in visual performance, associated with changes in the number, size and density of the stromal keratocytes.9,10 Stromal haze rarely persists beyond 12 months.5,7

Refractive outcome

By 12 months, 87–99% of low and medium myopes (<–6.00D) are within ±1D of emmetropia. Enhancement procedures can be performed to correct residual refractive error, but predictability is not as good as for the initial procedure. Diurnal variations that result from PRK are clinically insignificant and any shift tends to be in the hyperopic

Table 5.2 Grading of haze post-PRK7

Grade of haze

Description

0

Clear

0.5

Haze barely detectable

1

Mild haze, refraction unaffected

1.5

Mild haze that affects refraction

2

Moderate haze, refraction difficult, high-contrast vision affected

3

Opacity prevents refraction, vision impaired, anterior chamber visible

4

Opacity impairs view of anterior chamber

5

Unable to see anterior chamber

direction, and therefore has little or no impact on vision.11,12 The reduction in atmospheric pressure and reduced oxygen levels found at high altitude have been shown to result in temporary, but significant, peripheral corneal thickening in PRK subjects. This does not appear to be associated with any refractive shift.13

Complications specific to PRK

Persistent haze

Up to grade 1.5 haze (on a 0–4 scale) is expected during the first 2–3 months postPRK, but more significant haze may develop in those treated for higher refractive errors and in those with darker irides.14 Intense and persistent haze may require the use of topical corticosteroids. Research into wound healing post-PRK suggests that anti-transforming growth factor-B (TGF- B) and mitomycin may help to prevent and treat stromal haze in the future.15

Anisometropia

Most clinics and surgeons perform PRK on patient’s eyes unilaterally. It is usual to have an interval of a few months between the PRK for each eye, during which time some patients find the level of anisometropia between the eyes uncomfortable. This is especially difficult immediately prior the second operation, as the patient will have to cease contact lens use in preparation for the next operation.

Epithelium irregularity

PRK involves removal of the corneal epithelium pre-operatively and subsequent re-epithelialization of the cornea, and some patients have reported recurrent corneal erosions. This may be troublesome for patients with seasonal ocular allergies and many patients feel the need for occasional ocular lubrication.

Laser in-situ keratomileusis

Immediately post-surgery

Immediately after laser in situ keratomileusis (LASIK), a slit lamp should be used to check the flap position and look for wrinkles, striae (Figure 5.1) or significant interface debris that may require the flap to be re-floated by the surgeon.16 Failure to do so could result in a compromised visual performance because of significant corneal irregularity over the pupil. No fluorescein staining should be visible, other than a little around the flap margins, but some degree of anterior chamber activity is relatively common.1,17 If fluorescein reveals an epithelial defect (Figure 5.2), corticosteroids can be used to prevent or at least limit interface inflammation. In the majority of cases, functional vision returns within a few hours of surgery, with 80% achieving

Figure 5.1

Striae post-LASIK. (Courtesy of Michelle Hanratty)

a level of vision within one line of their preoperative BCVA by 3 days after LASIK.18 Patients may experience grittiness, photophobia and perhaps burning for the first 24 hours until the epithelium around the flap margin has healed, but discomfort can generally be controlled using anti-inflammato- ry drops (e.g., 0.5% diclofenac sodium, extended release) rather than a bandage contact lens19 Eye rubbing or squeezing can dislodge or distort the flap during the early post-operative period, so the patient is usually fitted with a transparent eye shield to minimize the risk of this happening.

At 1 week

The epithelium should fully cover the flap margin by 1 week post-LASIK. The margins can be quite difficult to detect at this stage, as fibrosis has yet to take place. Epithelial defects should be monitored carefully, since they increase the risk of epithelial ingrowth and diffuse lamellar keratitis (DLK). Interface debris should also be watched as it may lead to focal infiltrates that require flap re-floatation. Topographical irregularities and sub-clin- ical flap oedema complicate objective and subjective refraction and limit visual quality in the early post-operative period.

At 1 month

By this stage, the vision tends to be very good. However, as the novelty of clear vision without glasses begins to wear off, some patients start to notice visual problems such as reduced-quality night vision and haloes around lights. The refractive error may have stabilized in those treated for lower degrees of myopia (<6.00DS), although regression of approximately 15% of the pre-operative error is not uncommon20 (e.g., –0.25D after LASIK for –1.50D, and –1.50D after LASIK for –10.00D), and is associated with an increase in corneal thickness and central corneal steepening.21 If epithelial ingrowth is going to develop it tends to do so within the first month. The clinician must then

Post-operative follow-up of the refractive surgery patient 37

Figure 5.2

Flap-edge defect post-LASIK. (Courtesy of Michelle Hanratty)

decide whether the location and extent of the ingrowth warrant intervention.

At 3 months

After LASIK, healing is limited to the region around the lamellar interface and haze occurs around the flap margin only. Histological investigations show a regular stromal architecture, in contrast to the obvious anterior stromal disorganization seen after PRK.22 Most LASIK patients demonstrate a stable refractive error by 3 months, with the exception of those treated for very high myopia.23,24 The possibility of an enhancement procedure can be discussed if the refractive outcome is poor, but few surgeons consider an enhancement unless the residual error is greater than 1.00DS. LASIK enhancements are usually performed between 3 and 6 months after the first procedure. At this stage, the flap can still be lifted after removal of the epithelium from around the margin. Flaps in some patients can be lifted more than 18 months post-sur- gery.25 Late enhancements require a second lamellar cut, which increases the risk of complications.26 If an enhancement procedure is to be considered, both the refraction and corneal topography must be stable and there must be sufficient residual corneal thickness. As with the pre-opera- tive examination, a cycloplegic refraction is essential to minimize the risk of overcorrection. Any enhancement obviously requires the follow-up period to begin again.

At 6 months and beyond

The percentage of eyes that achieve within ±1.00D of emmetropia has been quot-

ed as 88–100% at 6 months post-LASIK for corrections of –8.00D or less.27,28 To

correct low hypermetropia, hyperopic LASIK has proved slightly more successful than hyperopic PRK,29 but the stabilization rate is approximately four times longer than for myopic treatments.30 As with PRK, there is no evidence of a diurnal variation in vision, although a temporary

increase in myopia and an associated reduction in vision have been reported at high altitude after LASIK.31

Complications specific to LASIK

Complications can arise from either the flap or, less commonly, the laser ablation.32 Flap complications include those that occur at the time of surgery (in approximately 0.3% of cases), such as an incomplete or decentred flap,33 and complications that present

after surgery, such as flap striae and epithelial ingrowth.32,34 The vast majority of

complications manifest themselves within 6–8 weeks of LASIK surgery. Most can be treated and have a minimal effect on the final outcome after surgery, if managed properly.35 Serious adverse complications that lead to a significant permanent visual loss, such as infections and corneal ectasia, are very rare, but side effects such as dry eyes, night-time starbursts and reduced contrast sensitivity are relatively common for the first few months.36 Surgeon experience is a key factor in the initial outcome.

Epithelial ingrowth

Epithelial ingrowth occurs when nests of epithelial cells trapped beneath the flap begin to proliferate (Figure 5.3). Ingrowth presents as a milky deposit in the interface (Figure 5.4) and is more common after

Figure 5.3

Nests of proliferating epithelial cells trapped beneath the flap can result in epithelial ingrowth. (Courtesy of Michelle Hanratty)

Figure 5.4

Ingrowth often presents as a milky deposit in the interface. (Courtesy of Michelle Hanratty)

38 Refractive surgery: a guide to assessment and management

enhancement than after the initial procedure. The extent should be measured since growth less than 1.0mm from the flap margin is acceptable, as it is usually self-limiting. Ingrowth greater than 1.0mm, invading the visual axis or progressing rapidly requires surgical management, particularly if the flap margin is rolled or eroded, as it can lead to significant irregularity and flap melt. Although a small degree of ingrowth is common (approximately 15% of eyes), few cases require management. Untreated ingrowth can lead to corneal irregularity and glare, and very occasionally to corneal melt.

Microstriae

Fine grey lines that are related to crinkles in Bowman’s membrane are not uncommon in those treated for moderate or high myopia, as the flap does not fit the remodelled stromal bed. Such cases are difficult to manage and are usually left alone unless vision is compromised.

Interface debris

Some debris is seen in virtually all eyes postLASIK. Sources include dust from the atmosphere, meibomian secretions (Figure 5.5), metallic deposits and oils from the microkeratome blade and fibres (Figure 5.6). Debris is usually inert and causes no problems, but it can be associated with stromal infiltrates or DLK, in which case it requires treatment with topical corticosteroids.

Figure 5.5

Post-LASIK interference debris. (Courtesy of Michelle Hanratty)

Figure 5.6

Fibres trapped in the interface post-LASIK. (Courtesy of Michelle Hanratty)

Diffuse lamellar keratitis (Sands of the Sahara)

DLK is a sterile, diffuse inflammation at the level of the interface that may be accompanied by anterior chamber activity (Figure 5.7).37 It looks a little like post-PRK haze, but is very obviously confined to the interface. It is thought to be an immune response to interface debris or perhaps bacterial toxins. The onset tends to occur within a day or two of the LASIK procedure, with symptoms such as pain and photophobia, and additional signs of ciliary hyperaemia and lacrimation. Visual quality may be reduced because of the increase in forward light scatter, although Snellen acuity is unaffected generally. Referral back to the operating surgeon is required for treatment with topical corticosteroids such as fluorometholone, antibiotics and cycloplegics. The flap may be lifted and irrigated in some cases.

A number of systems are used to grade DLK, including one that divides cases into one of four categories (Table 5.3). A cluster is defined as a group of DLK cases that occur in patients treated on the same day. One study found that DLK occurred in 1.3% of eyes treated, with 58% and 42% showing type I and type II, respectively. Cases with central involvement (type II) took significantly longer (12.1 days) to resolve than cases with central sparing (type I – 3.5 days). Not surprisingly, central involvement carries a much higher risk of a reduction in BCVA. The majority of cases were sporadic rather than part of

Figure 5.7

DLK is a sterile, diffuse inflammation at the level of the interface. (Courtesy of Michelle Hanratty)

a cluster.38 DLK can also present many months after LASIK in association with an epithelial defect.39 White blood cells migrate from the limbal blood vessels into the interface, since it is the easiest path for them to take. Central corneal sparing is much more likely if the DLK is related to an epithelial defect. There is also a reported case of DLK that occurred 10 months post-LASIK in association with acute iritis,40 which suggests that DLK is a nonspecific corneal inflammatory response rather than a condition caused by a particular agent. Appropriate management of patients with DLK generally results in complete resolution of the condition.

Corneal integrity

Concern has been raised as to the integrity of the globe post-LASIK, since healing does not appear to lead to the growth of collagen fibres between the corneal flap and the ablated stromal bed. The flap is attached to the underlying cornea only at its margins, by the corneal epithelium, and therefore does not contribute significantly to the strength of the cornea. However, a study that examined the integrity of the globe after a range of different refractive surgery procedures concluded that, although LASIK eyes required slightly less energy to rupture than control eyes, the difference was not significant.41 LASIK eyes ruptured either at the flap margin or at the edge of the limbus. Other studies have also concluded that ocular integrity is not compromised by LASIK.42,43 The risk of the flap being dislodged is very low, with one study on rabbit eyes showing no flap damage even at 1 week post-LASIK, when an airgun was fired at the edge of the flap.44 This can be attributed to the endothelial pump and the multiple layers of corneal epithelium that cover the flap margin. In a few isolated reports of flap

damage, this occurred with 2 months of the procedure.45,46 However, one study

reported flap dislocation 6 months postLASIK after focal trauma from a tree branch.47 This suggests that flap dislocation can occur at any time if the trauma is discrete and from such an angle that it catches the edge of the flap. Patient’s who report with flap dislocation should be referred urgently to the operating surgeon

Table 5.3 Classification of DLK38

 

No central involvement

Central involvement

Sporadic case

Type IA

Type IIA

Case part of a cluster

Type IB

Type IIB

for irrigation and refloating of the flap, followed by a course of topical antibiotics and corticosteroids, since DLK and epithelial ingrowth are common after such an occurrence.

Keratectasia

Keratectasia is a rare condition in which surgically induced corneal thinning leads to protrusion of the corneal tissue, an increase in myopia and irregular astigmatism, and consequently to a reduction in visual performance.48 Some cases require a corneal graft to achieve functional vision. This is a severe complication

that may not present for a year or more post-surgery (mean of 1 ± 0.3 years).49,50

Most cases of keratectasia can be attributed to miscalculation of the remaining corneal thickness. The general consensus is that keratectasia can be avoided by ensuring that the residual stromal bed after creation of the flap is at least 250μm in thickness. Unless the thickness of the stromal bed is measured intra-operatively, it is not always possible to ensure that adequate thickness remains because of the limited accuracy of microkeratomes, (standard deviation of ±30μm).

Iatrogenic ectasia is most commonly

associated with the treatment of high myopia (>–15.00DS),24,49,51 since a

deeper ablation is required and residual corneal thickness calculations become much more critical. A recent study of 2873 eyes reported ectasia in 0.66%.52 The authors noted that ectasia did not occur in those treated for less than –8.00DS or those with a residual corneal bed thickness of 325μm or more.52 Studies have suggested that there maybe more to ectasia than simply inadequate residual corneal thickness. The anterior 100–120μm of the corneal stroma is known to have a more tightly interwoven anterior lamellae than the underlying stroma,53 which makes this part of the stroma stronger and more resistant to swelling than the deeper layers. Differences between individuals in their stromal structure may mean some corneas are innately susceptible to developing ectasia. Examination of the biomechanics of the cornea after severance of anterior lamellae during the creation of the flap and the reshaping of the underlying stroma suggests that the whole cornea, including the posterior

surface, bows forwards as a result of surgery.54,55 This movement, which has also

been implicated in the refractive regression seen post-LASIK, suggests that the anterior lamellae play an important structural role.

Post-operative follow-up of the refractive surgery patient 39

Retinal complications

The risk of retinal detachment increases with increasing myopia above –3.00D, and highly myopic eyes (greater than –10D) also have an increased risk of primary open angle glaucoma, pigment dispersion syn-

drome, cataracts and myopic maculopa- thy.56–59 In theory, creation of the corneal

flap could lead to retinal complications, such as retinal tears or rhegmatogenous retinal detachment, particularly in susceptible individuals. A large study of almost 30,000 eyes reported vitreopathologic conditions in only 0.06% of eyes post-LASIK.60 Since the average onset was 13.9 months post-surgery, these cases might have been unrelated to the surgery and simply the result of myopic retinal degeneration. This highlights the importance both of a thorough retinal examination with scleral indentation (to allow the identification and treatment of retinal lesions prior to surgery) and of the education of all patients in the importance of regular eye examinations post-surgery.

Laser subepithelial keratectomy

Immediately post-surgery

After laser subepithelial keratectomy (LASEK), the epithelial flap should be examined to ensure that it is as smooth as possible. A bandage contact lens is often fitted over the flap to hold it in place. Plano silicon hydrogel lenses (e.g., Ciba Night and Day or Bausch and Lomb Purevision), or medium water content, non-ionic lenses (e.g., Bausch and Lomb Soflens 66) are popular options. All topical medication instilled into an eye that has a bandage lens should be preservative free (e.g., Minims chloramphenicol). Bandage lenses are associated with an increased risk of infection and infiltrates and therefore eyes fitted with a lens should be monitored carefully. Lens removal on day three or four should be accompanied by copious irrigation to prevent damage to the fragile epithelium. If flap damage occurs at any point during the procedure and the epithelial layer cannot be saved, the patient should be managed as if he or she had undergone a PRK procedure.

At 1 week

The epithelium should be examined to ensure that it is intact, but by 1 week the flap should have been replaced by new epithelial cells that migrate from the limbus. There is a rapid recovery of vision following LASEK – in one recent study of 222 eyes (range from –1D to –11D), 98% of the eyes achieved 6/12 unaided vision at the 2 week examination.61

At 1 month

LASEK produces less haze than does PRK,62,63 and therefore there is little to see

at 1 month. The cornea should be checked for fluorescein staining.

At 3 months

For the treatment of low and medium myopia (<–6.50DS), differences in unaided vision and refractive outcome between LASEK and PRK are insignificant by 3 months post-surgery.63

Refractive outcome

Of 222 eyes, 63% achieved 6/6 unaided vision at 1 year.61 The procedure appears to be safe, since no eyes showed a reduction in BCVA despite the wide range of preoperative myopia.

Complications common to all forms of excimer laser surgery

Undercorrection

Residual myopia is usually the result of an inaccurate pre-operative refraction or an insufficient period free of contact lenses prior to surgery. Enhancement can be considered once the refraction has stabilized.

Overcorrection

An initial hyperopic result is to be expected after PRK, but if hyperopia greater than 1.00D with minimal haze formation is still present 6 weeks post-surgery, the patient may be an ‘under-healer’64 and require a hyperopic enhancement. Hyperopic treatments are not as successful as myopic procedures, with a relatively high risk of regression, irregularity and a long stabilization period.

Regression

Regression is the loss of refractive effect over time and is more common following larger refractive corrections, particularly after PRK. A degree of regression is expected during the first 6 weeks post-PRK and the first 3 weeks post-LASIK, and is associated with stromal remodelling, thickening of the epithelium and corneal biomechanics.21,65 Severe regression associated with intense haze is very rare now that PRK is limited to the treatment of low myopia. The risk of regression is much higher in all people exposed to high levels of ultraviolet radiation (natural sunlight and sun beds), and in females who take oral contraceptives.66

Dry eye

Grittiness and asthenopia associated with dry eye are relatively common during the first 6 months post-excimer laser surgery. A number of possible causes include damage to the

40 Refractive surgery: a guide to assessment and management

conjunctival goblet cells by the lid speculum and impaired corneal sensitivity.67–69 Preservative-free ocular lubricants throughout the day (e.g., carmellose) and an ointment at night (e.g., liquid paraffin) normally suffice. Punctal plugs can be useful in more severe cases and lid hygiene to maximize meibomian gland function is useful.

Intraocular pressure elevation

If corticosteroids are used to treat the intense haze of DLK, for example, a small proportion of patients will demonstrate a significant rise in intraocular pressure (IOP). Steroid responders require immediate referral for cessation of topical corticosteroids and possible beta-blocker treatment. When assessing IOP post-sur- gery, clinicians should note that all excimer laser techniques lead to an artificially low IOP reading,70 by about 2mmHg, which is related to the reduced thickness of the central cornea.

Stromal infiltrates

Infiltrates, both sterile and infectious, can occur in the presence of a bandage contact lens (post-PRK or -LASEK) or interface debris (post-LASIK). Sterile infiltrates are also associated with the use of nonsteroidal anti-inflammatory eye drops.71 These must be assumed to be infectious until proved otherwise and the patient referred back to the surgeon for topical antibiotics (infectious) or topical corticosteroids (sterile).

Corneal infections

Cases of infectious keratitis are rare, but both fungal and bacterial infections have

been reported in the early post-operative period.72,73 These can take the form of a

corneal ulcer with epithelial staining, infiltrates and stromal oedema, or be confined to the interface (LASIK). Rapid referral is necessary to identify the cultures and for intensive treatment, but a penetrating keratoplasty may be the only solution. Excimer laser procedures have also been known to reactivate the herpes simplex virus, of which the classic dendritic pattern should be a warning. Those at risk

should have been screened out prior to surgery.74,75

Visual outcome

Unaided vision

PRK

For low and medium degrees of myopia (<–6.00D), 88–99% achieve 6/12 or better (uncorrected vision), and 58–78%

achieve 6/6 or better by 12 months post- PRK.76–79

LASIK

For eyes treated for –9.50D or less, the percentage of eyes that achieve 6/6 or better has been quoted as 83%, with 6/12 vision

or better achieved by 86–100% at 6 months post-LASIK.27,28,80

LASEK

For a range of myopia up to –11.25D, an unaided vision of 6/4.5 was achieved by 19% of eyes, 6/6 by 63% of eyes and 6/7.5 by 18% of eyes.61

Visual complications

Poor unaided vision is a common reason for dissatisfaction post-surgery,81 particularly if the patient’s expectations are unrealistic. However, these cases can be managed with an enhancement procedure, spectacles or contact lenses to correct the residual error. Corneal refractive surgery procedures are designed to minimize refractive error, but in modifying the shape of the cornea, they also tend to alter the optical quality of the eye. In the majority of post-surgery patients, these changes are clinically insignificant, and result in no apparent loss of visual performance. One indicator of the safety of a refractive surgery procedure is the percentage of eyes that lose two or more lines of BCVA. Recent studies on myopes being treated for <–6.00D suggest that 0–1.8% of eyes lose

two or more lines of BCVA after PRK, compared to 0–1.2% post-LASIK.27,80 Further

work is needed to determine the corresponding percentage for LASEK, but initial studies suggest that the level of risk is similar.61 For all excimer laser procedures, the percentage of eyes that exhibit a reduction in visual acuity increases with the degree of pre-operative myopia. An unacceptably high percentage of patients (7.3%) treated for hypermetropia

>+4.00D were found to lose two or more lines of best-corrected acuity,82,83 and

therefore the majority of surgeons do not consider medium and high hypermetropes for corneal refractive procedures.

High-contrast acuity provides limited insight into visual quality in the real world, and a loss of high-contrast visual acuity tends to indicate a significant loss of visual quality. Of the many patients who exhibit normal levels of high-contrast BCVA post-surgery, a proportion complain of poor visual performance, particularly under low illumination. Also, a minority of patients have compromised vision and yet are unaware of it because they rarely find themselves in visually demanding environments.

Reasons for patients refusing treatment to their second eye include glare, haloes

and poor-quality night vision.84 A study of 690 patients who had undergone PRK reported that 92% of patients were satisfied with the surgical outcome, with the degree of satisfaction closely related to the post-operative uncorrected vision in the better eye. Approximately 30% of patients reported some problems with their night vision.81 The Refractive Status and Vision Profile (RSVP) questionnaire has established itself as a useful tool with which to assess patient views on visual outcome. The overall RSVP score has been shown to correlate with changes in patient satisfaction.85

The reduction in visual performance that can occur post-refractive surgery has been attributed to an increase in forwards scattered light within the eye and increased aberrations (optical imperfections). Active keratocytes and disorganized collagen fibrils within the post-operative cornea act as scatter sources, scattering light both forwards (towards the retina) and backwards (towards the observer – e.g., stromal haze). The stray light is superimposed over the retinal image, which reduces its contrast. A reduction in the contrast of a high-contrast image, such as a Snellen letter, has limited impact on the ability of the eye to discriminate it – the letter will still be visible, just slightly fainter. Reducing the contrast of a low-contrast image is likely to result in the image contrast falling below the threshold for discrimination, that is the detail of the object will no longer be visible. Scattered light can cause disability glare (image degradation) in all individuals in the presence of a significant glare source, such as car headlights, but those who have raised levels of intraocular light scatter suffer reduced vision, even when there is no bright glare source, because light is scattered from one part of the retinal image to another.

To date, most refractive procedures have concentrated on correcting spherical and cylindrical refractive errors, which constitute approximately 97% of all aberrations. The eye naturally possesses higher order aberrations, which are known to increase with age.86 Axial aberrations are known to be the most problematic in terms of visual performance, particularly spherical aberration and coma. Both are highly dependent on pupil size and, on average, there is between a fiveand

seven-fold increase in total aberrations as the pupil dilates from 3 to 7mm.87,88 The

problem for most patients is not that traditional excimer laser procedures cannot correct these aberrations, but that both PRK and LASIK actually induce a significant and permanent increase in the aber-

rations.89–93 An increase in total aberra-

tions of between 25 and 300 times has been reported for a 7mm pupil.87,88 Coma

is associated with decentration of the ablation zone in relation to the pupil centre and increases with increasing preoperative refractive error. The degree to which the aberrations of the eye increase varies considerably between individuals.

Previous studies reported a high incidence of night-vision problems (such as

haloes, starbursts and poor-quality night vision) after laser surgery.94–96 These

problems were associated with high levels of stromal haze, which caused stray light, and with treatment zones significantly smaller than the average pupil, which led to extreme aberrations. Nowadays, haze is less common and much less severe because high myopes are no longer treated with PRK. LASIK and LASEK cause little or no haze in the majority of cases and ablation zone diameters for all techniques have increased from around 4 or 5mm up to 6 or 6.5mm, which makes them larger than or the same size as the average pupil under low illumination.

PRK

Forward light scatter is known to increase during the first 2 weeks postPRK, peaking at 3 months and returning to normal levels comparable to those of spectacle wearers and soft contact lens wearers by 12 months.97,98 However, evidence suggests that the distribution of light scatter around the retinal image is permanently modified by PRK, with an increase in the spread of stray light leading to a reduction in retinal image con-

trast.99 PRK has also been shown to induce higher order aberrations.88–100

Since both forwards scatter and aberrations cause a reduction in the retinal image contrast, low-contrast acuity and

contrast sensitivity are affected for the first 3 months,101,102 with permanent

changes in a minority of cases that exhibit large aberrations or persistent scatter.103 High-contrast acuity is only affected in severe cases. Studies indicate that visual performance under dilated pupil conditions (low illumination) may be compromised for a year or more, par-

ticularly for low-contrast acuity tasks.104,105

LASIK

Forward light scatter does not appear to increase significantly following LASIK,99 unless the patient suffers from DLK.

Higher-order aberrations are known to increase following LASIK,87,106 and spher-

Post-operative follow-up of the refractive surgery patient 41

ical aberration is thought to be greater after LASIK than after PRK, since the ablation zone is often smaller87 and creation of the flap leads to an increase in aberrations independently of the ablation profile. Limited study has been made of the effects of LASIK on visual performance, but there are suggestions that problems are less common and less severe than those that result from PRK. Some studies suggest that contrast sensitivity for high and medium spa-

tial frequencies is reduced for the first 3 months,107–109 although some spatial fre-

quencies do not appear to fully recover before 6 months.110 There is evidence that mesopic contrast sensitivity is reduced once photopic sensitivity has returned to normal.105 Contrast discrimination thresholds are persistently raised for many LASIK subjects compared to untreated subjects, but the ‘real-world’ significance of such findings is difficult to predict.111

LASEK

Since LASEK is a relatively new development, its impact on scattered light, aberrations and visual performance has yet to be considered. However, the procedure is very similar to that of PRK and therefore the outcome is likely to be similar to PRK and LASIK. Less forward light scatter would be expected than is seen after PRK because of the limited stromal haze, but aberrations are likely to be similar.

Managing patients with visual symptoms

Patients with visual problems should be questioned carefully about their symptoms. There is a tendency to gloss over problems that do not significantly impact on high-contrast acuity or cannot be attributed to slit-lamp or topography findings. It is essential that practitioners incorporate suitable tests into their assessment to obtain a full picture of any visual problems and hence select the correct management strategy. The percentage of patients who suffer from a significant

reduction in visual performance may be as high as 10–15%,85,111 but this is likely to

reduce in the future as wavefront technology improves and becomes more readily available. Although such technology is unlikely to live up to the initial expectations that it would create ‘super’ vision in a high proportion of patients, it should reduce levels of induced aberrations and provide some hope for those who already suffer from high levels of surgically induced aberrations.

Modification of standard assessment techniques

Vision and visual acuity measurement

Most optometrists and ophthalmologists rely on the Snellen chart, but the benefits of a logMAR chart are considerable if the data are to be analyzed and/or published.112 Bailey–Lovie logMAR charts, for example, use equal numbers of letters per line and have equal increments of change of letter size between the lines. Further information can be obtained from patients, where necessary, by employing highand low-contrast logMAR charts, as outlined below.

Refraction

Autorefractors often give a poor measure of refractive error post-corneal surgery, as a result of the significant changes in corneal profile.113 Retinoscopy can also prove difficult because of irregularity of the reflex, particularly during the early post-operative period or when the ablation zone is decentred or very small compared to the pupil. A 3–4mm ‘pinhole’ can be helpful in such circumstances. The retinoscopy reflex can also detect some cases of corneal ectasia should it develop at a later stage (swirling reflex). Subjective refraction is also complicated by both any irregularity and the multifocal nature of the post-operative cornea. The increase in spherical aberration associated with treatment for myopia alters the equivalent defocus by 0.25D or more for large pupils (6mm) in 27% of eyes. The advantage for the patients is that they tend to see better than would be expected for their apparent refractive error, and the onset of presbyopia may be delayed. The disadvantage is a reduction in the quality of vision and a shift towards myopia with pupil dilation. As with contact lens patients, do not assume that visual symptoms are necessarily associated with the surgery.

Assessment of corneal profile

Keratometers are poorly suited to refractive surgery work because of the small area of the cornea from which the curvature is calculated, which does not enable sufficient information regarding the regularity of the cornea to be gathered. The strange shape of the post-operative cornea also means that the keratometry readings are inaccurate and useless for contact lens fitting or intraocular lens calculations.

It is essential that clinicians involved in the management of refractive surgery have access to topographic equipment and

42 Refractive surgery: a guide to assessment and management

are able to understand and assess the plots produced. On occasions the topography plot is influenced by artefacts such as the lids or a disrupted tear film, so it is worth viewing the Placido disc image prior to processing the image (not relevant for Orbscan). The choice of scale is critical, since treatment for myopia produces a generalized flattening of the central cornea and the absolute scale tends to obscure useful detail because of the large intervals. Although a normalized plot may not allow comparison with other eyes, it generally better reveals the ablation zone margin and irregularities of the scale that affect vision. A good post-PRK or -LASEK plot (myopia) shows a large central flattened area with smooth contours if an axial algorithm is employed. Tangential maps of the same eye reveal a smaller flat zone surrounded by a steep ring. Post-LASIK topographies tend to be less regular with discontinuous contours and localized areas of flattening. Often, a crescentshaped region that relates to the flap margin is visible. The corneal profile becomes smoother as the epithelium is modified post-surgery. Some systems can give an estimate of the potential acuity based on the irregularity of the cornea after compensation for any residual sphere or regular astigmatism, but they do not consider whole eye aberrations.

Particular topographical features that may signal problems include central islands, decentred ablations and irregularities. A central island is defined as a 2–4mm area with 1.5–3.5D of corneal steepening associated with undercorrection, more common after treatment with a broad-beam laser.114 They tend to subside over the first year.115 Decentrations of the ablation in the region of 0.5mm are very common and tend to cause a slight reduction in visual quality, related to an increase in higher order aberrations (coma), but rarely a reduction in high-contrast acuity. Larger decentrations can cause monocular diplopia, irregular astigmatism and a loss of BCVA. Such cases require retreatment, ideally using a laser with a topographic or wavefront link. Decentrations may be symptom free if the pupil itself is slightly decentred.

Slit-lamp examination

A detailed examination of the anterior segment, including the anterior chamber, is essential on every follow-up visit. By varying the magnification and the illumination technique employed, complications can be identified quickly. Retroillumination is particularly useful in revealing complications such as flap microstriae, interface debris and ectasia.

Assessment of visual quality

High-contrast acuity alone is inadequate to assess the visual outcome of refractive surgery and patient satisfaction correlates poorly with visual acuity.116 Any residual refractive error must be corrected when assessing visual quality, as optical defocus attenuates high spatial frequencies. All tests of contrast vision have their limitations and it is difficult to compare the results of different tests, since they employ different stimuli, measurement techniques and, often, different light levels. The full contrast-sensitivity function can be determined by finding the contrast at which an eye can detect a series of sine wave gratings of different spatial frequencies. However, this is very time consuming and is generally reserved for the field of research. The Contrast Acuity Assessment (CAA) test is a computer-based psychophysical test that measures contrast acuity over the central ±5° field and is able to determine whether visual performance falls within the normal range under both photopic and mesopic conditions. Thresholds for those with an increase in forward light scatter and aberrations are elevated.117

In practice, one simple method is to compare highand low-contrast acuity measurements, but it is important that both letter charts are logMAR rather than Snellen, to allow accurate scoring and to overcome other drawbacks of the Snellen chart, such as the non-geometric letter size progression between lines and the variation in the number of letters per line.118 Normal subjects show a difference of approximately one line of letters between highand low-contrast acuity (10% contrast), but those who suffer from an increase in forward light scatter and/or aberrations will have reduced low-contrast acuity, which results in a larger difference between the two. The Pelli–Robson chart is easy to use and shows good repeatability if each letter is scored individually.119 The chart examines mid spatial frequencies close to the peak of the contrast-sen- sitivity curve, which are known to be affected by refractive surgery.110 Normal scores vary with age,120 and are around 1.84 for those between 20 and 40 years, reducing to around 1.68 for those over 60 years.

An assessment of performance under dim illumination can provide additional information, particularly in those who complain of night-vision problems. Measurements of pupil diameter should ideally be made using an infrared pupillometer that allows assessments at very low light levels.

Glare testing is an indirect way to assess intraocular light scatter. Like contrast-sen- sitivity testing, glare tests vary considerably and result in a wide range of outcomes. In general, they are not particularly useful since the increased retinal illumination that results from the glare source tends to cause pupil constriction and hence an improvement in visual performance.121 The City University Light Scatter Program is a computer-based psychophysical technique that can measure forward light scatter directly.122 However, it is rather time consuming and therefore maybe not currently suitable for clinical use.

Specific visual symptoms

Poor-quality vision

If a patient is symptomatic under daylight conditions, he or she is also very likely to experience problems at night. Poor contrast vision under photopic conditions when the pupil is relatively small can often indicate poor central optical quality within the pupil area. This may relate to an increase in aberrations or an irregularity caused by flap striae, epithelial ingrowth, and so on. Examination of the topography plot may help identify the problem, although such irregularities are often too subtle to detect. Rigid contact lenses may improve visual quality and, in future, wavefront technology may allow induced irregular aberrations to be corrected. The cornea should also be examined for haze, although the quantity of forward light scatter cannot be directly predicted from backscatter.123

Poor-quality night vision

Night vision in the normal population is relatively poor compared to vision under good illumination. Firstly, the dark-adapt- ed retina relies on the rod receptors, which have poor resolution compared to cone receptors and are more sensitive to scattered light within the eye. Secondly, pupil dilation is associated with an increase in aberrations. The peripheral cornea is known to scatter more light than the central cornea, so pupil dilation also increases the stray light within the eye.124 Thirdly, the contrast of an object against its background tends to be much lower at night and so any reduction in image contrast as a result of scatter or aberrations is more likely to render the object invisible. Visual difficulties at night may also relate to the presence of intense glare sources, such as car headlights, which further reduce contrast. If the ablation zone is larger than the pupil, but well

Post-operative follow-up of the refractive surgery patient 43

centred, visual problems are likely to be related to aberrations (including irregularities) and scattered light within the ablated area. A rigid contact lens may help, as it provides a smooth refracting surface. Ideally, an enhancement procedure is needed to correct induced aberrations, but wavefront technology is still in its infancy and the ability to correct aberrations is not as advanced as the ability to measure them; the healing response of the eye adds further unpredictability. A decentred zone gives rise to visual problems that relate to coma and, if severe, the patient may complain of monocular diplopia or polyopia.

Haloes

Individuals with particularly large pupils under low illumination may suffer from an extreme version of positive spherical aberration. Peripheral light rays pass through the untreated cornea and superimpose an unfocussed image over the clear retinal

image to give the appearance of haloes around lights at night.94,125 Haloes are

more common in eyes that have undergone small-diameter ablations, and in patients with naturally large pupils (6.5–7.0mm in diameter). Ablation diameters of 6.0mm or more have significantly reduced halo problems in the majority of patients, although Roberts and Koester126 suggested the use of even larger diameter ablations for ‘at risk’ groups (i.e., young patients with large pupils, those with deep anterior chambers and patients in occupations for which glare is of serious concern). Some laser software quotes the complete zone size, including the transition zone, rather than the optic zone size. Those with significant haloes may benefit from a further excimer treatment to increase the ablation zone, which has been shown to reduce symptoms in seven out of ten cases without any significant change in refraction.127 Topical miotic drops, such as 0.25% or 0.5% pilocarpine, can provide temporary relief, although pilocarpine can cause headaches and blurred vision.128 Carbachol is an alternative that has fewer side effects. Patients can be comforted by the fact that the pupil diameter does decrease with age.

Starburst effects

Starburst effects are related to forward light scatter and high cellular activity postPRK. They tend to subside over time as haze resolves. Many patients confuse starburst effects, haloes, glare and even photophobia. In such cases more details may need to be obtained through subjective questioning, as well as testing methods.

Contact lens fitting post-refractive surgery

In some cases, the only solution to visual problems may be to fit the patient with contact lenses. However, it should be realized by the contact lens clinician that many patients opt for refractive surgery because of the inconvenience perceived with contact lens wear. It is, therefore, advisable that negative commentary by the contact lens clinician be avoided. Soft contact lenses are suitable for those with a simple underor overcorrection associated with a regular cornea and, as long as an ultrathin lens is chosen, there is no need to use a specialist lens designed for oblate corneas.129 Aspheric soft lenses designed to minimize aberrations (e.g., Ultravision) can reduce symptoms in those with severe night-vision complaints and may provide a reasonable alternative to miotics. Soft lenses should not be fitted after radial keratotomy (RK) because of the high risk that neovascularization will be induced along the radial incisions.

Some post-surgery patients require a contact lens to correct surgically induced irregularities. In such cases a rigid lens provides a smooth refracting surface, but fitting is complicated by the change in corneal profile from prolate to oblate, which necessitates a reverse geometry lens or, at least, a back surface aspheric. Materials should be of mid-to-high Dk, but the most important factor is good material stability. Trial lenses are essential to determine lens power, back optic zone radius (BOZR; Table 5.4) and back optic zone diameter (BOZD).

When fitting a back surface aspheric lens, the lens should be centrally positioned with a degree of clearance over the flattened ablation zone, a 1–2mm ring of light touch in the mid-periphery and an

Table 5.4 Selection of BOZR for first trial lens post-refractive surgery

Source of curvature information

First BOZR selected

Pre-operative K readings

0.1 to 0.2mm flatter than flattest K

(or from second untreated eye)

 

Post-operative K readings

0.2 to 0.3mm steeper than flattest K

edge lift of approximately 0.3–0.6mm. The central clearance results in a positive tear lens that necessitates compensation of the lens power. Reverse geometry lenses have a second curve that is steeper than the BOZR by 0.6–1.2mm, to achieve midperipheral alignment without excessive central pooling. Topography can be used to improve fitting success, but careful selection of the most informative plot is essential.

Binocular vision problems

In a few susceptible individuals, surgical reduction of the refractive error can affect their binocular status. Spectacles for myopia may effectively control an exophoric deviation and, likewise, hypermetropic corrections can control esodeviations. Changes in the accommodative convergence:accommodation (AC:A) ratio are adapted to easily by the majority of patients, but a careful pre-operative assessment is essential to identify those who might suffer from binocular vision problems post-surgery; a prismatic correction is difficult to incorporate in an effectively emmetropic correction.

Non-tolerance of monovision

A number of patients opt for monovision to delay their need for reading glasses once they reach presbyopia. In general, monovision is well tolerated, and only about 4% of patients require an enhancement procedure to correct both eyes for distance in cases of non-tolerance.130 The majority of monovision patients achieve good binocular visual acuity and adapt quickly. Binocular summation and a degree of stereopsis (40–800 seconds of arc) remain as long as the difference between the two eyes is no more than about 1.50D.131 Non-tolerant patients may complain of disorientation and blurred distance vision. Those who suffer from motion sickness are less likely to adapt to monovision, but this should be revealed by the pre-operative monovision contact lens trial. Non-toler- ance is more common if the dominant eye has been corrected for near vision rather than for distance, although many individuals can tolerate this situation given time.132 Some patients report haloes around lights at night as the brain attempts to fuse the blurred retinal image in the near eye with the clear image in the eye corrected for distance. Patients must be made aware that the advantages of a monovision correction reduce as accommodative power reduces with age, although a +1.50D addition should allow functional vision for most basic day-to-day tasks. Around 20% of patients benefit

44 Refractive surgery: a guide to assessment and management

from a balancing spectacle overcorrection for detailed tasks such as driving at night or computer use.

Long-term implications of refractive surgery

It is not uncommon to hear concerns voiced about the possible long-term implications of PRK and LASIK, since routine excimer laser surgery has only been available for around 15 years. However, it should be stressed that eye care clinicians who continue to inform their patients that excimer laser surgery is still experimental or in its infancy are not only misinformed, but also passing on poor advice to their patients. Commonly raised concerns about long-term implications are outlined below.

Endothelial damage

The corneal endothelium does not appear to be affected adversely, with no significant alteration in central cell density,133 although an increase in the coefficient of variation of cell area and a decrease in the

percentage of hexagonal cells was reported in one study.134

Cancer risk

Examination of unscheduled DNA synthesis, a measure of the tissue repair mechanism, revealed no difference between the effects of an excimer laser and a diamond knife.135 Extensive animal studies have failed to establish a link between epithelial or connective tissue neoplasms and excimer laser exposure.

Risk of cataract

Short-term changes in the aqueous humour and prolonged biochemical changes in rabbit crystalline lenses in the form of free radicals have been detected after photoablation. These changes are thought to be the earliest signs of cataractogenic changes.136 However, no significant elevation of malondialdehyde (MDA) levels, a possible indicator of oxidative

effects, has been found after PRK on rabbits,137 and to date there has been no

increase in the incidence of cataract.

Clinical implications of refractive surgery

The increase in aberrations as a result of surgery can make refraction rather difficult to perform, particularly if the patient has large pupils. A large 3–4mm pinhole can prove useful during retinoscopy. When the aberrations are large, it is difficult to find a definite end point for the subjective refraction.

The change in corneal thickness after corneal refractive surgery has implications for the measurement of IOP. A thinner cornea causes underestimation of the IOP, since the resistance of the cornea to indentation is altered. The average surgical refractive correction reduces the central corneal thickness (CCT) by 10–15% (20% in a few high myopes), which leads to a 1–2mmHg decrease in measured pressure. Examination of a wide range of studies led Doughty to conclude that 2mmHg should be added to IOP measurements for each 10% reduction in CCT.70

Modification of the corneal profile also has implications for the calculation of a suitable intraocular lens power if the patient should undergo cataract surgery in the future. Ideally, surgical records should include a note of the patient’s pre-opera- tive keratometry readings, since post-oper-

ative keratometry readings misrepresent the power of the cornea,138 with the pos-

sibility of a significant refractive error postcataract surgery.

Radial keratotomy

Clinicians are unlikely to encounter new patients who have undergone RK, as the technique is now obsolete. However, problems can develop many years after incisional surgery and clinicians should be aware of the these and how to manage them.

Refractive stability

The long-term stability of the refractive result has been questioned following the detection of a drift towards hyperopia in up to one-third of patients after 4 years.139 The 10 year follow-up of the Prospective Evaluation of Radial Keratotomy (PERK) study revealed an alarming 43% of eyes with a hyperopic shift greater than 1.00D

from the refractive result at 6 months postRK.139,140 In theory, patients who exhib-

it a hyperopic shift could be referred to a surgeon for hyperopic excimer laser treatment – both PRK and LASIK procedures have been undertaken successfully after unsuccessful RK.141 However, hyperopic refractive errors, unless large, are usually tolerated well by younger patients and, since hyperopic treatments are less predictable than myopic corrections, a retreatment is probably best avoided. Exposure to high-altitude conditions has also been shown to cause a significant hyperopic shift (up to +1.50 ± 1.01D by day three) in those who have undergone RK, but the effect is reversible13

A relatively common complication of RK is a diurnal fluctuation in refractive error

and hence visual acuity, associated with a structurally weakened cornea.142–145 The

PERK study encountered an increase in myopia greater than –0.50D in 30% of eyes116 A study of firefighter applicants who had undergone RK found a myopic shift between morning and afternoon of –0.41 ± 0.33D compared to +0.06 ± 0.42D in the control group. The refractive change caused three out of 10 subjects to fail the unaided vision standard in the afternoon, despite passing in the morning.146 Unfortunately, patients who suffer from a significant diurnal variation have few options. Spectacles can be provided to correct the refractive error at its most myopic, but this is generally a poor compromise. Patients who cannot tolerate the fluctuations in vision have few options other than a corneal graft.

Ocular integrity

Corneal perforation is a serious, but very rare, complication of RK.147 The continuity of collagen fibrils is not restored after RK, and so the tensile strength of the cornea is reduced. A reduction in ocular integrity is not surprising, considering that micro-perforations of the cornea have been shown to occur in about 18% of eyes at the time of surgery; these induce significant alterations in the blood–aqueous barrier for the first week post-RK.1 The formation of an epithelial plug in an otherwise fully healed RK incision concentrates stress at the incision site, which may predispose the cornea to rupture. The variability in strength measurements between post-RK corneas indicates that the increase in rupture susceptibility is hard to predict, since it is dependent on the size of any epithelial plug and the strength of the wound collagen.148 One study reported three cases of corneal rupture more than 10 years after RK; these resulted from an assault, a sports injury and ‘daily living’.149 Another study considered 28 eyes that had ruptured some years after RK and attributed seven cases to an assault, four to sports injuries, five to car crashes and 12 to ‘daily living’.150 Wound leakage that resulted from blunt trauma has been reported 8 years after RK,151 and incision rupture has occurred during routine cataract surgery more than 11 years after RK.152 Following suturing of the wound, BCVA can return to normal levels, but a corneal graft may be the only answer for some patients. Clinicians are unlikely to encounter such unfortunate individuals

at the acute stage, but might see them some time after the incident if they experience problems associated with an irregular cornea.

Corneal infection that involves the incisions has been reported many years after surgery. Such patients are likely to be in some discomfort and are more likely to present to casualty. Clinicians should look out for infiltrates, oedema and fluorescein staining (rather than pooling) of incisions. The need for routine yearly or two-yearly eye examinations should be stressed to

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