NCT03023800已完成不适用
A Randomized, Open Label, Single Center Study Comparing the Efficacy of Macular Buckle Versus Vitrectomy + Internal Limiting Membrane Peeling + Gas Tamponade on Macular Schisis and Concurrent Macular Detachment in Eyes With Highly Myopia
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Retinal re-attachment rate
研究概览
简要总结
Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.
详细描述
A randomized, open label, single center study comparing the efficacy of macular muckle + gas injection versus internal limiting membrane peeling + gas tamponade on macular schisis associated with macular detachment in eyes with high myopia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •axial length ≥ 26.5 mm or refractive error (spherical equivalent) ≥ 8.0 diopter
- •macular schisis
- •macular retinal detachment
- •evidence of posterior staphyloma on clinical examination
排除标准
- •severe macular scar
- •macular detachment which extended to the peripheral retina (i.e., extension beyond the major vascular arcades in more than one quadrant)
- •prominent vitreomacular traction
- •a history of vitrectomy or macular buckle
- •intraocular active hemorrhage or inflammation
- •any media opacity which precluded imaging or clinical evaluation of the macula
结局指标
主要结局
Retinal re-attachment rate
时间窗: 3 month
次要结局
- Post-operative best corrected visual acuity(12 month)
- Post-operative macular structure on optical coherance tomography(12 month)
研究者
Lin Lu
Director of Fundus Disease Center
Sun Yat-sen University
研究点 (1)
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