Vitrectomy and Inverted Flap or Internal Limiting Membrane Peeling in Small Full Thickness Macular Holes
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Microperimetry retinal sensitivity
研究概览
简要总结
Primary outcome: difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique Secondary outcomes: difference of visual change after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique; difference in closure rate after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •idiopathic full thickness macular hole ≤ 350 micron of diameter
- •phakic or pseudophakic
- •absence of systemic adverse conditions
排除标准
- •concomitant retinal and other ocular disease
- •previous ocular surgery except cataract surgery
- •axial length >26mm
研究组 & 干预措施
inverted flap
干预措施: inverted flap (Procedure)
peeling internal limiting membrane (ILM)
干预措施: peeling internal limiting membrane (ILM) (Procedure)
结局指标
主要结局
Microperimetry retinal sensitivity
时间窗: 3 months
Difference of microperimetry retinal sensitivity after primary vitrectomy for idiopathic full thickness macular holes with inverted flap technique versus internal limiting membrane (ILM) peeling technique
次要结局
- Best corrected visual acuity (BCVA)(3 months)
- Closure rate(3 months)
研究者
Michele Reibaldi
Prof.
University of Turin, Italy