SCORE Study report 3: study design and baseline characteristics.
SCORE Study report 3: study design and baseline characteristics.
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DOI:
10.1016/j.ophtha.2009.03.022
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发表时间:
2009-09
期刊:
影响因子:
13.7
通讯作者:
SCORE Study Investigator Group
中科院分区:
文献类型:
--
作者:
Ip MS;Oden NL;Scott IU;VanVeldhuisen PC;Blodi BA;Figueroa M;Antoszyk A;Elman M;SCORE Study Investigator Group
To describe the baseline characteristics of the participants in the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study and to compare with cohorts from other retinal vein occlusion trials. The design of the SCORE Study is also described. Two multicenter phase 3 randomized clinical trials, one involving participants with central retinal vein occlusion (CRVO) and one involving participants with branch retinal vein occlusion (BRVO). 682 participants, including 271 with CRVO and 411 with BRVO. Demographic and study eye characteristics are summarized and compared between the CRVO and BRVO study participants. Baseline ophthalmic characteristics, including visual acuity and duration of macular edema prior to enrollment, and medical history characteristics, including diabetes mellitus and hypertension. In the CRVO trial, at baseline, mean visual acuity letter score was 51 (∼20/100), mean optical coherence tomography (OCT)-measured central subfield thickness was 595 microns, mean area of retinal thickening in the macular grid on color photography was 12.3 disc areas and mean area of fluorescein leakage was 11.0 disc areas. In the BRVO trial, at baseline, mean visual acuity letter score was 57 (∼20/80), mean OCT-measured central subfield thickness was 491 microns, mean area of retinal thickening in the macular grid on color photography was 7.5 disc areas and the mean area of fluorescein leakage was 6.1 disc areas. Differences observed in baseline visual acuity, OCT-measured retinal thickness, area of retinal thickening on color photography and area of fluorescein leakage support the evaluation of CRVO and BRVO in separate trials.
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