1. Spectral-domain optical coherence tomography in subjects over 60 years of age, and its implications for designing clinical trials.
- Author
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Caramoy A, Foerster J, Allakhiarova E, Hoyng CB, Dröge K, Kirchhof B, and Fauser S
- Subjects
- Age Factors, Aged, Cross-Sectional Studies, Databases, Factual, Female, Humans, Macular Degeneration therapy, Male, Middle Aged, Refraction, Ocular, Reproducibility of Results, Research Design, Retrospective Studies, Tomography, Optical Coherence standards, Visual Acuity, Clinical Trials as Topic methods, Macular Degeneration pathology, Retina pathology, Tomography, Optical Coherence methods
- Abstract
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 µm and 281.02 µm 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 µm difference between both eyes was seen. To detect a change of at least 30 µm in CRT, a sample size of 90 or 176 per group is needed for a single-arm or double-arm study, respectively (α=0.05, power=0.80, no loss to follow up, assuming SD in future studies=100 µm)., Conclusions: Clinical trials using CRT as an endpoint are feasible in terms of sample size needed.
- Published
- 2012
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