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临床试验/NCT01165801
NCT01165801已完成4 期

Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery

The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2002年1月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
AMD size (defined central region of interest)

研究概览

简要总结

The purpose of this study was to find out if in patients with non-exudative age-related macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression or progression to exudative AMD could be detected 6 months after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with cataract and non-exudative age-related macular degeneration

排除标准

  • Patients with retinal pathologies other than AMD, exudative AMD, progressive glaucoma, myopia > 10 diopters, panretinal laser treatment, former cataract or vitreoretinal surgery, were excluded.

结局指标

主要结局

AMD size (defined central region of interest)

时间窗: at enrollment, after 6 months

To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.

次要结局

  • Functional ophthalmic assessments(at enrollment, after 6 months)

研究者

发起方
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
申办方类型
Other

研究点 (2)

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