Purpose: To evaluate test-retest variability in electroretinogram (ERG) responses in subjects without evidence of diffuse photoreceptor cell disease.
Design: Cohort study.
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.