Limited versus Conventional Internal limitingmembrane peeling in Macular hole surgery –Structural and functional outcomecomparison
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To compare structural outcome (Hole Closure) between two groups.
研究概览
简要总结
ILM peeling in macular hole surgery is done in macular area including the
papillomacular bundle. Since, papillomacular bundle carries the most crucial nerve fibres
from fovea to disc. We hypothesize that if we can avoid ILM peeling over the papillomacular
bundle, we may be able to prevent damage to the papillomacular bundle. However, less ILM
peeling may result in low closure rate. It has been shown that larger ILM peeled area causes
greater reduction of clinical symptoms of the patient.14
In this study, we plan to analyse structural and functional outcome in patients of
FTMH undergoing macular hole surgery using two techniques of BBG dye assisted ILM
peeling i.e. conventional in one group and limited (sparing ILM over the papillomacular
bundle in the second group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 50 years of age and of any gender
- •Patients either pseudophakic or phakic having primary idiopathic macular holes stage 3 and stage 4 with healthy optic nerve.
- •Macular hole of size less than 400 microns.
排除标准
- •1.Inability to maintain postoperative position
- •Previous ocular surgery 3.Traumatic macular holes 4.No other ocular disease apart from Macular hole such as glaucoma, corneal opacity and significant cataract 5.Media opacity not allowing good quality OCT scans •The patients were explained the study and consent process and the prospective participant were invited to take part in the study.
结局指标
主要结局
1. To compare structural outcome (Hole Closure) between two groups.
时间窗: Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3 | months postoperatively.
2. To compare functional outcome (Changes in Retinal thickness, RNFL thickness,
时间窗: Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3 | months postoperatively.
macular ganglion cell layer thickness and mf ERG amplitudes) between two groups
时间窗: Follow up of all patients will be done at baseline, day 1, day 7, 1 month and 3 | months postoperatively.
次要结局
- 1. To compare change BCVA in patients of two groups.(2. To compare change in choroidal thickness in patients of two groups)