Comparative evaluation of phacoemulsification combined with goniosynechialysis with or without Microhook ab interno Trabeculotomy in Primary angle closure glaucoma – A pilot randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs PhacoGSL(PG) in PACD
研究概览
简要总结
| Primary Objective |
To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs PhacoGSL(PG) in PACD
Secondary Objectives
To compare
· Reduction in number of anti glaucoma medications
· BCVA
· Post operative complications
· Change in angle parameters on ASOCT
· Correlation of ITC with gonioscopic findings and final reduction in IOP
· compare postoperative incisional cross-sectional area and correlate with IOP reduction
· TM tissue will be sent for scanning electron microscopy analysis whenever possible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary Angle Closure disease patients with cataract (who received laser peripheral iridotomy at least 8 weeks before) Age more than or equal to 40 years Patients willing to give consent.
排除标准
- 未提供
结局指标
主要结局
To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs PhacoGSL(PG) in PACD
时间窗: To compare the reduction in IOP in PhacoGSL+Microlot (PGM) vs PhacoGSL(PG) in PACD at baseline with | day 1, 1 week, 4 weeks, 3 months, 6 months, 12 months
次要结局
- To compare(•Reduction in number of anti glaucoma medications)
研究者
ROHAN SUNIL SONAWANE
AIIMS, NEW DELHI