Elsevier

Ophthalmology

Volume 110, Issue 6, June 2003, Pages 1159-1163
Ophthalmology

Variability of full-field electroretinogram responses in subjects without diffuse photoreceptor cell disease

https://doi.org/10.1016/S0161-6420(03)00253-7Get rights and content

Abstract

Purpose

To evaluate test–retest variability in electroretinogram (ERG) responses in subjects without evidence of diffuse photoreceptor cell disease.

Participants

Forty subjects without diffuse photoreceptor cell disease.

Methods

Serial ERGs were performed on 40 subjects (mean age at the time of first ERG: 54 years; range: 38–75 years) over a period of 2 to 6 years. These subjects participated in a study by a pharmaceutical company investigating the effects of certain drugs, used for gastrointestinal disorders, on retinal function. None of the subjects showed any evidence of progressive change in retinal function related to the medications. The ERG responses that were evaluated included amplitudes and implicit times for the dark-adapted rod-isolated and rod-dominant responses, light-adapted single flash response, and both light- and dark-adapted 31-Hz flicker responses.

Main outcome measures

The data were analyzed by using analysis of variance methods, and a threshold criteria for significant change with 95% confidence was calculated for implicit times and an increase or decrease in ERG amplitudes.

Results

The threshold for significant change varied depending on the ERG stimulus. For the dark-adapted stimuli, a significant decrease in amplitude varied from 35% to 42% as compared with a variation of 53% to 73% for a significant increase. For the light-adapted stimuli, a significant decrease in amplitude varied by 52% as compared with a variation of 109% to 110% for a significant increase. The threshold for significant change for implicit times varied from 3.0 milliseconds to 8.7 milliseconds.

Conclusions

The measured test–retest variability in ERG amplitudes and implicit times in subjects without diffuse photoreceptor cell disease underscores the importance of conducting similar comprehensive studies of variability in patients with acquired and hereditary retinal diseases. These data are also of value for monitoring disease progression and in future therapeutic trials.

Section snippets

Materials and methods

Electroretinography data were collected prospectively from 66 subjects participating in a study sponsored by a pharmaceutical company. In this study, ERG recordings were used as an objective measure of retinal function in monitoring any possible ill-effects from the use of proton pump and nonproton pump medications for gastroesophageal reflux disease, including Zollinger-Ellison syndrome. All except 7 subjects participating in the study had a normal ERG at baseline. Subjects were excluded if

Results

The threshold criteria for significant change (with 95% confidence) in implicit time and for a decrease or an increase in ERG amplitude in response to different stimuli are shown in Table 1. Results for each eye were determined separately and then combined.

Values from each eye were used to determine a range of test–retest variability. For the dark-adapted ERG stimuli, a decrease in amplitude was significant if it declined by 40% for the rod-isolated blue flash, 35% for the rod-dominant white

Discussion

Test–retest variability has not, to our knowledge, previously been published regarding subjects with no known retinal pathologic features. Our results, however, can only be compared with the limited information available from earlier studies on patients. In a prospective, natural history study in patients with retinitis pigmentosa (RP) or cone–rod dystrophy,3 intervisit variability was measured in a subset of 29 randomly selected patients who were tested twice within a 2-month period. They

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Manuscript no. 220031

The authors have no proprietary interest.

Supported by the Foundation Fighting Blindness, Hunt Valley, Maryland; the Grant Healthcare Foundation, Chicago, Illinois; the National Institutes of Health, Bethesda, Maryland (core grant no.: EYO1792); and Research to Prevent Blindness, Inc., New York, New York.

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