Spectral-domain optical coherence tomography in subjects over 60 years of age, and its implications for designing clinical trials
SourceBritish Journal of Ophthalmology, 96, 10, (2012), pp. 1325-1330
Article / Letter to editor
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British Journal of Ophthalmology
SubjectNCEBP 2: Evaluation of complex medical interventions IGMD 3: Genomic disorders and inherited multi-system disorders
AIMS: To study the variability of central retinal thickness (CRT), its concordance to the fellow eye, and the implications for designing future clinical trials using spectral-domain optical coherence tomography (SD-OCT). METHODS: Cross-sectional retrospective analysis of European Genetic Database. 632 eyes of 316 subjects over 60 years of age without macular pathology were examined using SD-OCT. RESULTS: Mean CRT was 280.22 microm and 281.02 microm for the right and left eyes, respectively. There was a strong concordance for all measured values between right and left eyes. Men had significantly thicker CRT than women. Variation up to 23 microm difference between both eyes was seen. To detect a change of at least 30 microm in CRT, a sample size of 90 or 176 per group is needed for a single-arm or double-arm study, respectively (alpha=0.05, power=0.80, no loss to follow up, assuming SD in future studies=100 microm). CONCLUSIONS: Clinical trials using CRT as an endpoint are feasible in terms of sample size needed.
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