Purchase this article with an account.
J. A. Elledge, B. A. Blodi, A. Domalpally, M. Ip, I. U. Scott, P. Van Veldhuisen, N. Oden, SCORE Study Investigator Group; Evaluation Procedures and Reproducibility of Evaluation Procedures for Color Fundus Photography and Fluorescein Angiograms in the Standard Care Versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5408.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To report the evaluation procedures and reproducibility of evaluation procedures for color fundus photographs (FP) and fluorescein angiograms (FA) in the Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study.
The SCORE Study consists of 2 multicenter randomized trials investigating the safety and efficacy of standard of care versus intravitreal triamcinolone to treat macular edema associated with central and branch retinal vein occlusion (RVO). Stereoscopic color FP and FA are evaluated by certified ocular disease evaluators (ODEs) using standardized procedures. FP are assessed for vein occlusion type as well as the area of retinal edema and the area of retinal hemorrhage within a 16 disc area ETDRS grid. FA are evaluated for the area of leakage and capillary loss within the grid. We present the first 2 out of 3 annual regrading exercises.
A randomly selected set of 99 images was identified for annual regrade. On color photography, intergrader agreement for type of vein occlusion was 97% for both regrades. At year 1, the intraclass correlation coefficient (ICC) is 0.76 for area of retinal thickening; 0.87 for area of retinal hemorrhage. On fluorescein angiography, the ICC is 0.75 for area of fluorescein leakage; 0.94 for area of capillary loss. At year 2, the ICC is 0.57 for retinal thickening and 0.88 for area of retinal hemorrhage when compared to baseline grades. FA evaluation at year 2 revealed an ICC of 0.66 for fluorescein leakage and 0.97 for area of capillary loss when compared to baseline grades.
Well-defined FP and FA grading procedures and regular quality control assessments show that good reproducibility can be achieved in clinical trials for retinal vein occlusions. However, there were two areas where the ICC was low in the second annual regrade; area of retinal thickening (0.57) and area of fluorescein leakage (0.66). We suspect that ODEs, originally trained in evaluating diabetic macular edema, a disease which typically has lesser areas of retinal thickening and fluorescein leakage than RVO, have changed their approach to grading RVO by correctly identifying larger areas of retinal thickening and fluorescein leakage by the time of the second annual regrade. The methodology used for assessing photographic and angiographic images is an important secondary outcome of the SCORE Study and is anticipated to be useful in future studies for the evaluation of RVO.
Clinical Trial: :
This PDF is available to Subscribers Only