Variability of choroidal and retinal thicknesses in healthy eyes using swept-source optical coherence tomography - Implications for designing clinical trials

Abstract

Aim: The aim was to study the variability of choroidal scleral interface (CSI) thickness in healthy subjects and its relevance for designing future studies. Methods: A total of 123 volunteers were imaged using swept-source optical coherence tomography. Early treatment diabetic retinopathy grid was used. Results: Mean central retinal thickness was 285.85±14.53 µm and 287.18±12.93 µm, and mean central CSI thickness was 273.94±77.77 µm and 271.19±78.85 µm for the right and left eyes, respectively. Mean retinal and CSI thicknesses correlated negatively with age (p=0.023, r=-0.208 and p,0.0001, r=-0.426, respectively) and axial length (p=0.016, r=-0.220 and p,0.0001, r=-0.504, respectively). To detect a CSI change of at least 112 µm, a sample size of 11 or 36 per group is needed for a single- or double-arm study, respectively (α=0.05, power =0.90, no loss to follow-up, assuming standard deviation in future studies as 100 µm). Conclusion: Future clinical studies using CSI as end point are possible with regard to sample size needed.