临床试验/NCT01202461

NCT01202461已完成1 期

Three-year Result of Triple Therapy of Vitrectomy, Intravitreal Triamcinolone and Macular Laser Photocoagulation for Intractable Diabetic Macular Edema

Samsung Medical Center2 个研究点分布在 2 个国家目标入组 41 人开始时间: 2010年8月最近更新: 2010年9月15日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Samsung Medical Center
入组人数: 41
试验地点: 2
主要终点: Best-corrected visual acuity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to report 3-year result of triple therapy of vitrectomy, intravitreal triamcinolone and macular laser photocoagulation for intractable diabetic macular edema.

Previously author reported 1-year result(Am J Ophthalmol. 2007 Dec;144(6):878-885. Epub 2007 Oct 15.).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 20 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•clinical diagnosis of diabetes mellitus
•intractable diffuse DME (diffuse DME which did not respond to or recurred after the previous IVTA and/or macular focal laser photocoagulation)
•central subfield macular thickness (CST) greater than 250μm

排除标准

•presence of vitreomacular traction
•a prior history of treatment for the DME within 3 months or vitreoretinal surgery

结局指标

主要结局

Best-corrected visual acuity

时间窗: At baseline, 6,12,24,36 months after surgery

Measurement of visual acuity at every visit. VA at every visit was compared from VA at baseline

次要结局

Central subfield macular thickness(0,6,12,24,36 months after surgery)

研究者

发起方

Samsung Medical Center

申办方类型

Other

研究点 (2)

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