Caramoy, Albert, Foerster, Jonathan, Allakhiarova, Elvira, Hoyng, Carel B., Droge, Katharina, Kirchhof, Bernd and Fauser, Sascha (2012). Spectral-domain optical coherence tomography in subjects over 60 years of age, and its implications for designing clinical trials. Br. J. Ophthalmol., 96 (10). S. 1325 - 1331. LONDON: BMJ PUBLISHING GROUP. ISSN 1468-2079

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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 mu m and 281.02 mu m 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 mu m difference between both eyes was seen. To detect a change of at least 30 mu m 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 mu). Conclusions Clinical trials using CRT as an endpoint are feasible in terms of sample size needed.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Caramoy, AlbertUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Foerster, JonathanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Allakhiarova, ElviraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hoyng, Carel B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Droge, KatharinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kirchhof, BerndUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fauser, SaschaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-481694
DOI: 10.1136/bjophthalmol-2012-301885
Journal or Publication Title: Br. J. Ophthalmol.
Volume: 96
Number: 10
Page Range: S. 1325 - 1331
Date: 2012
Publisher: BMJ PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1468-2079
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
DIABETIC MACULAR EDEMA; AXIAL LENGTH; FLUORESCEIN ANGIOGRAPHY; RETINAL THICKNESS; HEALTHY-SUBJECTS; DETACHMENT; EYES; SEXMultiple languages
OphthalmologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/48169

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