Comparative Evaluation Of Conventional Macular Hole Surgery With Inverted Internal Limiting Membrane Flap Technique For Large Macular Holes - A Prospective Randomized Study
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Best corrected visual acuity
研究概览
简要总结
Large macular holes usually have an increased risk of failure. Flat open macular holes are associated with limited visual acuity. This study compares conventional macular hole surgery with inverted Internal Limiting Membrane Flap technique in patients with large macular holes. Study design will be a prospective comparative study. Patients with macular holes larger than 600 microns will be included . In group 1 15 eyes will undergo standard 3 port pars plana vitrectomy with air and in group 2 15 eyes will undergo inverted ILM flap technique. Primary outcome measures are best corrected visual acuity and post operative macular hole closure , Investigations will de bone pre operatively and on follow up at 1 week, 1 month,3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Eyes with large macular holes(more than 600 microns in least diameter) 2.Macular Hole Index less than or equal to 0.4 3.Non traumatic idiopathic holes 4.Phakic/Pseudophakic eyes 5.Informed consent 6.Older than 18 years.
排除标准
- •1.Optic disc diseases like glaucoma, AMD and optic atrophy due to other causes 2.Diabetic retinopathy or maculopathy 3.Eyes with retinal detachment 4.Lens opacity or cataract 5.Inability to follow up.
结局指标
主要结局
1.Best corrected visual acuity
时间窗: Pre operative, at 1 week, 1 month and 3 months
2.SD-OCT
时间窗: Pre operative, at 1 week, 1 month and 3 months
次要结局
- 1.Autofluorescence Imaging(2.Multifocal ERG)