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SCORE研究报告3:研究设计与基线特征

SCORE Study report 3: study design and baseline characteristics.

作者信息

Ip Michael S, Oden Neal L, Scott Ingrid U, VanVeldhuisen Paul C, Blodi Barbara A, Figueroa Maria, Antoszyk Andrew, Elman Michael

机构信息

University of Wisconsin Fundus Photograph Reading Center, Madison, WI, USA.

出版信息

Ophthalmology. 2009 Sep;116(9):1770-1777.e1. doi: 10.1016/j.ophtha.2009.03.022. Epub 2009 Jul 19.

Abstract

OBJECTIVE

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.

DESIGN

Two, multicenter, Phase III, randomized clinical trials, one involving participants with central retinal vein occlusion (CRVO) and one involving participants with branch retinal vein occlusion (BRVO).

PARTICIPANTS

A total of 682 participants, including 271 with CRVO and 411 with BRVO.

METHODS

Demographic and study eye characteristics are summarized and compared between the CRVO and BRVO study participants.

MAIN OUTCOME MEASURES

Baseline ophthalmic characteristics, including visual acuity and duration of macular edema before enrollment, and medical history characteristics, including diabetes mellitus and hypertension.

RESULTS

In the CRVO trial, at baseline, mean visual acuity letter score was 51 ( approximately 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 (DA), and mean area of fluorescein leakage was 11.0 DA. In the BRVO trial, at baseline, mean visual acuity letter score was 57 ( approximately 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 DA, and the mean area of fluorescein leakage was 6.1 DA.

CONCLUSIONS

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.

FINANCIAL DISCLOSURE(S): The authors have no proprietary or commercial interest in any of the materials discussed in this article.

摘要

目的

描述视网膜静脉阻塞标准治疗与皮质类固醇治疗(SCORE)研究参与者的基线特征,并与其他视网膜静脉阻塞试验的队列进行比较。同时介绍SCORE研究的设计。

设计

两项多中心III期随机临床试验,一项涉及中心性视网膜静脉阻塞(CRVO)参与者,另一项涉及分支视网膜静脉阻塞(BRVO)参与者。

参与者

共682名参与者,其中271名患有CRVO,411名患有BRVO。

方法

总结并比较CRVO和BRVO研究参与者的人口统计学和研究眼特征。

主要观察指标

基线眼科特征,包括入组前的视力和黄斑水肿持续时间,以及病史特征,包括糖尿病和高血压。

结果

在CRVO试验中,基线时,平均视力字母评分是51(约20/100),光学相干断层扫描(OCT)测量的中心子野厚度平均为595微米,彩色眼底照相黄斑网格中视网膜增厚的平均面积为12.3视盘面积(DA),荧光素渗漏的平均面积为11.0 DA。在BRVO试验中,基线时,平均视力字母评分是57(约20/80),OCT测量的中心子野厚度平均为491微米,彩色眼底照相黄斑网格中视网膜增厚的平均面积为7.5 DA,荧光素渗漏的平均面积为6.1 DA。

结论

在基线视力、OCT测量的视网膜厚度、彩色眼底照相的视网膜增厚面积和荧光素渗漏面积方面观察到的差异支持在单独试验中对CRVO和BRVO进行评估。

财务披露

作者对本文讨论的任何材料均无所有权或商业利益。

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