CTRI/2024/06/069209尚未招募1 期
Comparison of efficacy between descemetorhexis without endothelial keratoplasty (DWEK) with or without topical rho kinase inhibitor in Fuch’s endothelial corneal dystrophy (FECD).
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in central corneal thickness
研究概览
简要总结
This study is a randomized, single blinded , clinical trial comparing the efficacy between descemetorhexis without endothelial keratoplasty (DWEK) with or without topical rho kinase inhibitor in fuch’s endothelial corneal dystrophy (FECD) that will be conducted in Guru nanak eye centre comprising 12 per group of sample. Primary outcome is change in Central corneal thickness at 6 months and secondary outcome is change in endothelial cell count at central cornea and periphery at 6 months .
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with Fuchs dystrophy diagnosed clinically with cataract .
- •Dense central guttae limited to central 5mm of cornea .
- •Central stromal edema with visually significant complaints, morning blur .
- •Clear peripheral cornea with an endothelial cell count of more than 1000 cells / mm square .
排除标准
- •Advanced corneal edema defined as the presence of bullae or scarring .
- •Presence of secondary corneal pathology such as infective or autoimmune keratitis .
- •All patients with any retinal pathology ,advanced glaucoma corneal edema other than FECD.
- •Patients on hormonal therapy /Oral contraceptive pills.
结局指标
主要结局
Change in central corneal thickness
时间窗: Preop ,post op day 1 ,at 1 month ,then monthly till 6 months
次要结局
- Change in endothelial cell count in central and periphery .(6 months)
研究者
Dr Parul Jain
Guru Nanak Eye Centre
研究点 (1)
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