A Randomised Controlled Trial to Evaluate the Efficacy of Sub-Tenon Mitomycin C Trabeculectomy with and without Amniotic Membrane Transplantation as an Adjunct in a Tertiary Care Centre
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomy
研究概览
简要总结
A Randomised Controlled Trial evaluating the efficacy of amniotic membrane transplantation as an adjunct in sub-tenon MMC-augmented trabeculectomy. in a sample size of 42 eyes. Patients diagnosed with primary open-angle glaucoma and primary angle closure glaucoma are included and divided into control and study groups. The control group will undergo trabeculectomy with Sub-tenon Mitomycin C alone and the study group will undergo trabeculectomy with Sub-tenon Mitomycin C combined with AMT. The patients will be selected according to a Computerized Randomisation chart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of open-angle glaucoma and angle-closure glaucoma fulfilling the following criteria were included 1.IOP more than 21 mmHg despite using IOP-lowering medications 2.Patients willing for 3-month follow-up and investigations.
排除标准
- •A history of prior surgical interventions in the form of past glaucoma filtering surgery, cataract surgery, or any other surgery involving conjunctiva, or co-existing conjunctival disease.
结局指标
主要结局
This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomy
时间窗: pre-operative | post operative 3 month
次要结局
- This study will provide further insight into the efficacy of amniotic membrane transplantation as an adjunct to sub-tenon Mitomycin trabeculectomy(post operative day 1)
研究者
Dr Siddhant Relekar
Shri B .M .Patil Medical College Hospital and Research centre