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CHAPTER 1. STUDIES ON DIABETIC RETINOPATHY

Overview

In this chapter, we will show you how to locate peer-reviewed references and studies on diabetic retinopathy.

The Combined Health Information Database

The Combined Health Information Database summarizes studies across numerous federal agencies. To limit your investigation to research studies and diabetic retinopathy, you will need to use the advanced search options. First, go to http://chid.nih.gov/index.html. From there, select the “Detailed Search” option (or go directly to that page with the following hyperlink: http://chid.nih.gov/detail/detail.html). The trick in extracting studies is found in the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the format option “Journal Article.” At the top of the search form, select the number of records you would like to see (we recommend 100) and check the box to display “whole records.” We recommend that you type “diabetic retinopathy” (or synonyms) into the “For these words:” box. Consider using the option “anywhere in record” to make your search as broad as possible. If you want to limit the search to only a particular field, such as the title of the journal, then select this option in the “Search in these fields” drop box. The following is what you can expect from this type of search:

•Diabetic Retinopathy: A Clinical Overview

Source: Diabetes Care. 15(12): 1844-1874. December 1992.

Summary: After an introductory summary, this review article describes the natural course of diabetic retinopathy, then briefly considers selected pathogenetic and epidemiological concepts. A discussion of current treatment concludes the article. Specific topics include diabetic retinopathy and blood glucose control; the classification of retinopathy; and treatment modalities, including antiplatelet agents, photocoagulation, and vitrectomy. 24 figures. 7 tables. 146 references. (AA-M).

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•Anemia: A Risk Factor for Diabetic Retinopathy?

Source: Practical Diabetology. 20(4): 32-34. December 2001.

Contact: Available from R.A. Rapaport Publishing, Inc. 150 West 22nd Street, New York, NY 10011. (212) 989-0200 or (773) 777-6801.

Summary: Diabetic retinopathy (eye disease associated with diabetes) continues to be a major problem in the United States. This article reviews the risk factors for diabetic retinopathy and then presents a case report that supports the idea that anemia needs to be added to the list of risk factors. Retinal hypoxia (reduced amounts of oxygen being delivered to the retina) has long been associated with the development of diabetic retinopathy; anemia is one of the conditions that can contribute to retinal hypoxia. The authors discuss the clinical features, mechanism of injury from anemia, and relationship between retinopathy and hemoglobin level. The authors conclude by suggesting laboratory evaluation for anemia in patients with diabetes who may have an increased risk of developing anemia. This group includes pregnant women, women with menorrhagia (loss of large amounts of blood with their menstruation), postoperative patients, patients with renal (kidney) failure, patients with neoplastic processes (including cancer), patients with gastrointestinal bleeding, and patients with poor blood glucose control. Normalization of hemoglobin levels may stabilize progressive retinopathy. 9 references.

•Exercise for Patients with Diabetic Retinopathy (commentary)

Source: Diabetes Care. 18(1): 130-132. January 1995.

Contact: Available from American Diabetes Association. 1701 North Beauregard Street, Alexandria, VA 22311. (800) 232-3472. Website: www.diabetes.org.

Summary: In this article about diabetic retinopathy and exercise, the authors stress the importance of developing exercise prescriptions for individuals who have proliferative diabetic retinopathy (PDR) and other concurrent diabetic complications to improve their participation in normal daily activities and psychosocial well being, while minimizing the risk of further visual deterioration. The authors describe a research study that investigated diabetes education, psychosocial support, and exercise for diabetes patients with visual impairment. They also discuss balancing risk factors with the potential benefits of exercise; special adaptations in exercise programs; and concerns that exercise will precipitate a vitreoretinal hemorrhage. 10 references.

•Current Therapy of Diabetic Retinopathy: Laser and Vitreoretinal Surgery

Source: Journal of the National Medical Association. 85(11): 841-847. November 1993.

Summary: In this article, the author reviews the pathophysiology of diabetic retinopathy, delineates the types of diabetic retinopathy, and outlines treatment and management options. Specific topics include nonproliferative diabetic retinopathy (background), preproliferative diabetic retinopathy, proliferative diabetic retinopathy (PDR), management recommendations for each type of retinopathy, the use of laser photocoagulation, vitreous surgery, the indications and patient selection for these surgeries, and the prognosis for diabetic vitrectomized eyes. The author stresses that early detection and diagnosis of diabetic retinopathy will lead to earlier treatment and prevention of loss of sight. 5 figures. 2 tables. 11 references.

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•How Effective Are Treatments for Diabetic Retinopathy? (commentary)

Source: JAMA. Journal of the American Medical Association. 269(10): 1290-1291. March 10, 1993.

Summary: In this article, the author summarizes recent research projects that demonstrate the overall effectiveness of early identification and treatment of proliferative diabetic retinopathy (PDR) in preventing blindness. Clinical trials discussed include the Diabetic Retinopathy Study (DRS), the Diabetic Retinopathy

Vitrectomy Study (DRVS), and the Early Treatment Diabetic Retinopathy Study (ETDRS). The author stresses that the data from these studies, demonstrating that use of the currently recommended treatment strategies strikingly reduces the risk of blindness for patients with PDR, make full implementation of recommended treatments for diabetic retinopathy all the more imperative. The author concludes with a brief discussion of two preventive programs now being implemented and the need for professionals to support and participate in these programs. 1 figure. 12 references. (AA- M).

•C-Peptide and the Classification of Diabetes Mellitus Patients in the Early Treatment Diabetic Retinopathy Study: Report Number 6

Source: Annals of Epidemiology. 3(1): 9-17. January 1993.

Summary: The Early Treatment Diabetic Retinopathy Study (ETDRS), conducted at 22 clinical centers during the period 1980 to 1989, collected baseline data on C-peptide levels after ingestion of Sustacal in 582 patients with diabetes mellitus prior to enrollment in the trial. Data on several clinical factors associated with diabetes were also collected from all 3711 enrolled patients. This article describes how the C-peptide data were used to develop sets of clinical criteria for the classification of ETDRS patients and to compare and contrast definitions of type of diabetes used in previous studies. The authors conclude that a comparison of these previous studies revealed that even in the absence of C-peptide data, clinically derived definitions provided good discrimination between insulin-dependent and noninsulin-dependent diabetes. 5 tables. 35 references.

•Diabetes and Diabetic Retinopathy in a Mexican-American Population

Source: Diabetes Care. 24(7): 1204-1209. July 2001.

Contact: Available from American Diabetes Association. 1701 North Beauregard Street, Alexandria, VA 22311. (800) 232-3472. Website: www.diabetes.org.

Summary: This article describes a study that determined the prevalence rates of diabetes and diabetic retinopathy (DR) in a population based study, Proyecto VER (Vision Evaluation and Research), of Hispanics aged 40 years or older residing in Pima and Santa Cruz counties in Arizona. The study population consisted of 4,774 people who completed the examinations. Diabetes was defined as self report of a physician diagnosis or a glycosylated hemoglobin (HbA1c) value of 7 percent or more. DR was assessed on stereo fundus photographs of fields 1, 2, and 4. The study found that the prevalence of diabetes in the Hispanic community was 22 percent. The prevalence rate of DR was 48 percent, with 32 percent having moderate to severe nonproliferative and proliferative retinopathy. DR increased with increasing duration of diabetes and increasing level of HbA1c. The prevalence rate of DR like changes in the sample of individuals without diabetic retinopathy was 15 percent and was not associated with hypertension, systolic blood pressure, or diastolic blood pressure. The article concludes that the prevalence rate of diabetes in this population of Hispanics is high, almost twice

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that of Caucasians. The prevalence rate of DR is high but similar to reports in a Caucasian population. The prevalence rate of 9 percent moderate to severe retinopathy in the newly diagnosed group suggests that efforts to improve detection and treatment of diabetes in Hispanics may be warranted. 2 figures. 5 tables. 25 references. (AA-M).

•Results of 20 Years of Research on the Treatment of Diabetic Retinopathy

Source: Preventive Medicine. 23(5): 740-742. September 1994.

Contact: Available from Academic Press, Inc. 6277 Sea Harbor Drive, Orlando, FL 328874900.

Summary: This article describes four different multicenter randomized clinical trials on the treatment of diabetic retinopathy that were supported by the National Eye Institute. The trials include the Diabetic Retinopathy Study (DRS), the Diabetic Retinopathy

Vitrectomy Study (DRVS), the Sorbinil Retinopathy Trial, and the Early Treatment Diabetic Retinopathy Study (ET DRS). The author summarizes treatment recommendations based on these four trials. Scatter treatment should be deferred for eyes with mild or moderate nonproliferative diabetic retinopathy; to be considered again as the retinopathy progresses to the severe nonproliferative or early proliferative stages. Scatter photocoagulation should be performed for virtually all eyes with highrisk proliferative retinopathy. Early vitrectomy should be considered for advanced active proliferative diabetic retinopathy. Finally, and most importantly, all patients with diabetic retinopathy should receive careful follow-up. The author concludes that implementing the results from these clinical trials can markedly reduce the risk of blindness. 14 references. (AA-M).

•Management of Diabetic Retinopathy

Source: American Family Physician. 51(4): 785-796. March 1995.

Summary: This article for primary care physicians discusses diabetic retinopathy and its management. The author describes the two stages of retinopathy: the nonproliferative stage, which includes intraretinal microaneurysms, hemorrhages, and soft and hard exudates; and the proliferative stage, which is characterized by neovascularization and fibrovascular growth from the retina or optic nerve. Other topics covered include macular edema, complications that lead to blindness, the role of good glycemic control in reducing the development of retinopathy, the role of hypertension control, the importance of regular ophthalmologic examinations, and laser treatments. 14 figures. 2 tables. 23 references. (AA-M).

•Diabetic Retinopathy: The Primary Care Physician's Role in Management

Source: Postgraduate Medicine. 91(5): 141-144, 147, 150, 155-158. April 1992.

Summary: This article presents guidelines for the primary care physician's role in the management of diabetic retinopathy. Topics include the primary care evaluation of patients with diabetes, causes of visual loss in patients with diabetes, the types of diabetic retinopathy, and treatment modalities, including photocoagulation and vitrectomy. Types of retinopathy described are background retinopathy, including retinal edema, microaneurysms, retinal hemorrhages, cotton-wool spots, and intraretinal vascular changes; and proliferative retinopathy, including neovascularization, new vessel hemorrhage, and tractional retinal detachment. The author also reports on a recent socioeconomic study that investigated the cost of screening all patients with

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diabetes for significant retinopathy and the cost for treating the expected incidence of vision-threatening retinopathy. (AA-M).

•Aspirin Effects on Mortality and Morbidity in Patients With Diabetes Mellitus: Early Treatment Diabetic Retinopathy Study Report 14

Source: JAMA. Journal of American Medical Association. 268(10): 1292-1300. September 9, 1992.

Summary: This article presents information on the effects of aspirin on mortality, the occurrence of cardiovascular events, and the incidence of kidney disease in the patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS). Patients (n=3711) were enrolled in 22 clinical centers between April 1980 and July 1985. Men and women between the ages of 18 and 70 years with a clinical diagnosis of diabetes mellitus were eligible. Patients were randomly assigned to aspirin or placebo (two 325-mg tablets once per day). Results show that the effects of aspirin on any of the cardiovascular events considered in the ETDRS were not substantially different from the effects observed in other studies that included mainly nondiabetic persons. The ETDRS results support recommending aspirin for persons with diabetes at increased risk of cardiovascular disease. 2 figures. 7 tables. 35 references. (AA-M).

•Screening for Diabetic Retinopathy in Communities

Source: Diabetes Educator. 18(2): 115-120. March-April 1992.

Summary: This article reports on 12 retinopathy screening clinics, serving 489 patients with diabetes, that were conducted in 3 Michigan communities as part of an outreach effort. Screening activities were initiated by local diabetes educators who conducted a program designed to promote detection of diabetic eye disease and increase patient and health care provider awareness of accepted ophthalmic evaluation guidelines. The authors stress that three factors suggest that retinopathy screening clinics can be successfully conducted: if health care professionals in the community consider diabetic retinopathy to be a serious problem; if one individual is willing to oversee the organizational aspects of the clinic; and if an ophthalmologist with laser treatment capability is present or nearby. 4 tables. 10 references. (AA-M).

•Role of Growth Hormone in the Development of Diabetic Retinopathy

Source: Diabetes Care. 17(6): 531-534. June 1994.

Contact: Available from American Diabetes Association. 1701 North Beauregard Street, Alexandria, VA 22311. (800) 232-3472. Website: www.diabetes.org.

Summary: This article reports on a research study undertaken to determine the role of growth hormone (GH) in the development of diabetic retinopathy. In this study, the medical records of 1,423 patients who had undergone insulin tolerance tests at the Mayo Clinic were examined, and diabetic subjects) were identified as either GH deficient or GH sufficient. Prevalence of retinopathy was determined in these cases and in a cohort group of diabetic subjects selected to match the GH deficient cases. Despite comparable age, duration of diabetes, and metabolic control, the prevalence of diabetic retinopathy in the GH deficient group was less that that observed in the GH sufficient group. Prevalence in the GH deficient group also was lower than that observed in the cohort control group. The authors conclude that these data strongly suggest that GH contributes to the development of diabetic retinopathy in humans. 1 figure. 1 table. 26 references. (AA-M).

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•Screening for Diabetic Retinopathy

Source: Annals of Internal Medicine. 116(8): 660-671. April 15, 1992.

Summary: This article reports on a review of the literature designed to determine the appropriate patients, methods, and timing for screening for diabetic retinopathy. Relevant articles were identified through prominent review articles, the authors' files, recommendations from experts, and a MEDLINE search (1986 to the present); additional references were selected from the bibliographies of identified articles. After analyzing the data in the literature, the authors conclude that screening for retinopathy is justifiable if early detection leads to less vision loss at an acceptable cost. Topics include laser therapy, notably photocoagulation therapy; duration of diabetes as the main risk factor for retinopathy; the use of standard ophthalmologic examination versus sevenfield stereo-photography; and cost-effectiveness of screening programs. 3 figures. 2 tables. 74 references. (AA-M).

•Self-Rated Health and Diabetes of Long Duration: The Wisconsin Epidemiologic Study of Diabetic Retinopathy

Source: Diabetes Care. 21(2): 236-240. February 1998.

Contact: Available from American Diabetes Association. 1701 North Beauregard Street, Alexandria, VA 22311. (800) 232-3472. Website: www.diabetes.org.

Summary: This article reports on a study designed to evaluate the self reported quality of life in people with diabetes of long duration. The authors point out that many studies of self-rated health have found that individuals with diabetes score lower than individuals who do not have diabetes. Participants in the study included two cohorts of people with diabetes who had been followed in an epidemiological study periodically since 1980. Researchers assessed their responses using measures of self-rated health from the Medical Outcomes Study Short Form 36. According to the results of the study, physical function, physical role, general health scales, and a general question about health were related to diabetes characteristics in older-onset and younger-onset individuals. In both younger-onset and older-onset individuals, symptoms of sensory neuropathy were associated with these four measures. Other descriptive variables in the younger-onset group were the presence of nephropathy, cardiovascular disease, smoking, peak expiratory flow, physical activity, and glycosylated hemoglobin. Hypoglycemic reactions were of borderline significance for one scale (physical role). Cardiovascular disease, physical activity, and sex were descriptive of responses to the quality of life questions in older-onset individuals. The authors conclude that factors related to diabetes contribute to self-assessed health. Some of these factors may be modifiable and may lead to improved quality of life if altered. 5 tables. 22 references. (AA-M).

•Is There an Ethnic Difference in the Effect of Risk Factors for Diabetic Retinopathy?

Source: Annals of Epidemiology. 3(1): 2-8. January 1993.

Summary: This article reports on a study in which researchers compare the effect of established risk factors between Caucasians with diabetes (n=478) and MexicanAmericans with diabetes (n=231). The authors hypothesize that, in Mexican-Americans with diabetes, established risk factors may have a stronger effect on diabetic retinopathy, compared to Caucasians with diabetes. Retinopathy was classified into two categories (any or none) as assessed by seven standard stereoscopic retinal photographs. The Mexican-Americans had an increased prevalence of any retinopathy. Longer

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duration of diabetes, more severe glycemia, earlier age at diagnosis, and insulin therapy were associated with diabetic retinopathy in both Mexican-Americans and Caucasians. These findings suggest that a differential effect of risk factors in these two groups does not explain the higher prevalence of retinopathy complications in the MexicanAmerican group. 3 tables. 39 references. (AA-M).

•Opportunities for Cost Reduction in Diabetic Retinopathy Treatment: Case Study from Mexico

Source: Bulletin of the Pan American Health Organization. 28(1): 50-61. March 1994.

Summary: This article reports on a study performed to explore the costs of treating diabetic retinopathy at a large eye hospital in Mexico, in order to identify opportunities for improving efficiency. Clinical records of a random sample of 69 patients with diabetes were reviewed for data on each patient's background, medical history, and treatment; the costs of all resources utilized in each type of procedure provided were documented and priced. The resulting data on clinical costs was complemented by data on the private costs of treatment (medical fees, accommodation costs, transportation costs, and lost wages) that were gathered from patient interviews. Results showed that the patients, who were generally poor, shouldered a substantial economic burden associated with treatment at the hospital; however, less than half this burden was in the form of fees. The authors give suggestions for reducing of these costs without endangering treatment quality. 5 tables. 13 references. (AA-M).

•Diabetic Retinopathy in Oklahoma Indians With NIDDM: Incidence and Risk Factors

Source: Diabetes Care. 15(11): 1620-1627. November 1992.

Summary: This article reports on a study to determine the incidence rates and risk factors for diabetic retinopathy in Oklahoma Indians. The researchers performed a cohort followup study with baseline examination between 1972 and 1980 and followup examination between 1987 and 1991 (mean follow-up time was 12.8 years). Study participants included a quasi-random sample of 1,012 Native Americans (379 men, 633 women) who had noninsulin-dependent diabetes mellitus (NIDDM) with a duration of 6.9 years at baseline. At follow-up, 515 (55.6 percent) were alive, 408 (44 percent) were deceased, and 4 (0.4 percent) could not be traced. Results show that the incidence of retinopathy among the participants who were free of disease at baseline and who survived the followup interval was 72.3 percent. The authors investigate possible predictors of retinopathy, including systolic blood pressure, duration of diabetes, and therapeutic regimen. They conclude that, because NIDDM is reaching epidemic proportions in Oklahoma Indians and most may experience retinopathy, frequent ophthalmological examinations are indicated for this high-risk population. 2 figures. 4 tables. 32 references. (AA-M).

•Longitudinal Studies of Incidence and Progression of Diabetic Retinopathy Assessed by Retinal Photography in Pima Indians

Source: Diabetes Care. 26(2): 320-326. February 2003.

Contact: Available from American Diabetes Association. 1701 North Beauregard Street, Alexandria, VA 22311. (800) 232-3472. Website: www.diabetes.org.

Summary: This article reports on a study undertaken to examine incidence and progression of retinopathy (eye disease) using retinal photographs in Pima Indians and

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to compare the results with those obtained when retinopathy is assessed by direct ophthalmoscopy. The authors analyzed data from eye examinations of 411 people with diabetes who had at least two examinations between April 1982 and December 1990. Incidence and progression of retinopathy were evaluated by retinal photography and fundoscopy, and hazard rate ratios were calculated for various potential risk factors measured at baseline. Results showed that previously diagnosed retinopathy tended to progress, except in individuals with minimal nonproliferative retinopathy, among whom follow-up examinations were more likely to show not retinopathy. Diabetes duration, hyperglycemia (high blood glucose), the type of treatment for diabetes (insulin or oral hypoglycemic agents), and macroalbuminuria (protein in the urine) were associated with the development of retinopathy. Although fundoscopy detected fewer cases of retinopathy, risk ratios for most risk factors were similar when retinopathy was assessed by fundoscopy rather than retinal photography. The authors conclude that although retinopathy tends to worsen over time, some eyes show improvement, especially in patients with minimal nonproliferative retinopathy. As in other populations, glycemic control is the major modifiable risk factor for the development and progression of retinopathy. 3 figures. 3 tables. 24 references.

•Diabetic Retinopathy: Overlooked, Undertreated

Source: Patient Care. 29(3): 12. February 15, 1995.

Contact: Available from Medical Economics. 5 Paragon Drive, Montvale, NJ 07645. (201) 358-7200.

Summary: This brief article reminds readers of the role of early detection of diabetic retinopathy in preventing visual impairment. The author stresses that many patients with diabetes are unaware of the advances that have been made in the treatment of retinopathy in recent years. As a result, many cases of mild, potentially treatable visual impairment are allowed to progress and become debilitating. Other topics include recent refinements in laser and vitreous surgery; the role of early screening and treatment; economic factors, including differences between the costs of screening versus treatment; and American Diabetes Association screening recommendations. The author also briefly mentions the role of improved glucose control in delaying the onset of retinopathy in patients with IDDM. 5 references. (AA-M).

•Telemedicine: Opportunities and Challenges for the Remote Care of Diabetic Retinopathy (editorial)

Source: Archives of Ophthalmology. 117(12): 1639-1640. December 1999.

Contact: Available from American Medical Association. Subscriber Services Center, P.O. Box 10945, Chicago, IL 60610. (800) AMA-2350 or (312) 670-7827. Fax (312) 464-5831. E- mail: ama-subs@ama-assn.org.

Summary: This editorial comments on the use of telemedicine in the remote care of diabetic retinopathy. Although several studies have evaluated the accuracy of photographs or digital images and their appropriateness for diagnosing and monitoring diabetic retinopathy, there has been no clear organizing framework or structure for how these images or attendant remote care systems should be evaluated or used. Before telemedicine can be used to provide routine eye care for diabetes or other conditions, various issues must be addressed. The most important concern is to determine the purpose of any telemedicine system. Next, from an evaluation standpoint, the system's performance must be sufficient compared with the appropriate criterion standard. For example, any study demonstrating the value of remote care in diabetic retinopathy

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needs to establish its validity and reliability relative to established criterion. Third, the technical validity of remote care images needs to be established from a technical perspective. Lastly, there is a need for studies analyzing the implementation of remote eye care of patients who have diabetes in the community clinical setting. Any efforts to substitute telemedicine on a continuing, regular basis for the routine eye care of patients who have diabetes or any other disease before addressing these issues is to potentially risk the health and vision of patients. 14 references.

•Epidemiology of Proliferative Diabetic Retinopathy

Source: Diabetes Care. 15(12): 1875-1891. December 1992.

Summary: This review article examines recent epidemiological data about the prevalence and incidence of and risk factors for proliferative diabetic retinopathy. In addition, the relation of proliferative retinopathy to other systemic complications associated with diabetes is reviewed. The data come mostly from the baseline and 4-year follow-up examinations of a large population-based study, the Wisconsin Epidemiologic Study of Diabetes Retinopathy (WESDR), which involved 996 younger-onset and 1370 older-onset people with diabetes. The authors conclude that their data suggest that hyperglycemia and, possibly, high blood pressure are related to proliferative retinopathy. They reiterate the importance of routine ophthalmological examinations to detect and treat proliferative retinopathy. 5 figures. 10 tables. 159 references. (AA-M).

•What You Need to Know About Diabetic Retinopathy

Source: IM. Internal Medicine. 19(6): 18-26. June 1998.

Contact: Available from Medical Economics. 5 Paragon Drive, Montvale, NJ 07645. (800) 432-4570.

Summary: This review article provides primary care physicians with information on the nature of diabetic retinopathy and the preventive value of appropriate specialist referrals for patients with this condition. The article describes the course of diabetic retinopathy and discusses treatments tailored to the stage of the disease. Treatment of diabetic retinopathy usually involves laser photocoagulation, except in very advanced cases that require vitrectomy surgery. The article reviews evidence of the efficacy for these treatment methods. Various studies have demonstrated the benefit of photocoagulation treatment in eyes with high-risk proliferative retinopathy or clinically significant macular edema. Another study found an advantage of early vitrectomy surgery for people with type 1 diabetes with severe vitreous hemorrhage. The article offers guidelines for providing eye care for patients with diabetes and discusses the role of the primary care physician in instructing the patient in glycemic control. These physicians should teach and encourage tight glycemic control and keep in mind considerations concerning hypertension, hyperlipidemia, renal failure, cigarette smoking, pregnancy, and hypomagnesemia with regard to their patients with diabetes. In addition, the article lists and illustrates possible features of each stage of diabetic retinopathy and presents cases of diabetic retinopathy before and after treatment. 1 table. 28 references.

•Diabetic Retinopathy, Visual Acuity, and Medical Risk Indicators: A Continuous 10year Follow-up Study in Type 1 Diabetic Patients Under Routine Care

Source: Journal of Diabetes and its Complications. 15(6): 287-294. November-December 2001.