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68

G. Michelson et al.

 

 

7.2Patients and Methods

7.2.1Participants

The data used in this work were gathered in several cities in Germany in a cross-sectional survey with the goal to screen and to evaluate retinal vessels and the optic nerve [10, 11]. A total of 19,294 volunteers were taking part in the ongoing study from August 2002 until January 2004. We were interested in the age group 45Ð64 years, which reduced the number of eligible persons for evaluation to 9,602. This population consisted of 3,822 women and 5,780 men. The mean age of the population was 52.90 years with a standard deviation of 5.26 years. The mean age among women was 53.08 ± 5.29 years, among men it was 52.79 ± 5.24 years.

The major part of the participants (85%) was recruited in companies from the Siemens group; the remaining 15% came from several middleclass enterprises and public places (e.g., SBK ofÞces, Siemens-Betriebskrankenkasse, health insurance). The companies were selected by SBK, and all companies agreed by contract to provide the data for scientiÞc research. All departments were invited to participate in the study, and volunteers from these departments could register themselves. There were no inclusion or exclusion criteria; volunteers were examined on Þrst-come, Þrst-serve basis. The examinations took place in the working area.

The study was conducted in accordance with the Declaration of Helsinki on Biomedical Research Involving Human Subjects. The Clinical Investigation Ethics Committee of the University of Erlangen-NŸrnberg approved the study protocol. Written informed consent was obtained from all participants.

7.2.2Methods

All examinations were performed by staff members of the Private Tele-Ophthalmological Institute, Erlangen, Germany. The non-mydriatic fundus camera (KOWA NM-45, nonmyd-alpha, Japan), having a resolution of 1,216×1,600 pixels, was

used to create digital papilla-centered colored fundus images of both eyes of each participant. Using the non-mydriatic camera, there was no need to dilate pupils. Thus, interruptions in the working processes of the companies were minimized. Image size was 45¡ to allow evaluation of the optic nerve head plus retinal nerve Þbers. Within a profound interview, the participants were asked for their medical history and for their family history. By this interview, gender, age, presence of arterial hypertension, ocular hypertension, or family history of glaucoma were reported. Intraocular pressure (IOP) was not measured, but reported raised IOP was documented. The images and the medical history were stored on a server using web-based software (MedStage, talkingeyes & more GmbH, Siemens, Erlangen, Germany). Medical evaluation of the anonymized fundus images was done by a telemedical analysis: the ophthalmologists were able to download the images from the server and to examine them at the computers in their ofÞces. The images were inspected in Þve different magniÞcations and in three different color compositions (color image, red-free image, and green channel image). Figure 7.1 shows a screenshot of the evaluation software.

The standardized evaluation of the optic nerve head, the retina, and retinal vessels was done by one out of six experienced ophthalmologists. All images were examined based on a standardized protocol including retinal vessels (i.e., focal and generalized arterial narrowing, vessel tortuosity, thickened veins, microaneurysms, arteriovenous compression, retinal hemorrhages, venous beadings, neovascularization, and IRMA (intraretinal microvascular abnormalities)), the retina and macula (i.e., cotton wool spots, hard exudates, macular edema, and vitreous hemorrhage), and optic nerve head (i.e., suspected glaucomatous optic nerve atrophy, established glaucomatous optic nerve atrophy, simple optic atrophy, papillary drusen, myopic papillary degeneration, and optic nerve edema). The standardized examination protocol is also depicted in Fig. 7.1.

Evaluation of the images was performed using the option to zoom images and to examine them in different ways (color image, red-free image, and green channel image). The diameter of the