CTRI/2024/06/069279已完成1 期
Comparison of efficacy between accelerated epithelium-off and accelerated epithelium-on corneal collagen crosslinking in patients with keratoconus
Maulana Azad Medical College and associated Hospitals Guru nanak eye centre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1)Change in maximum keratometry (Kmax) at 6 months
研究概览
简要总结
This Prospective, randomized, comparative study compares the efficacy between accelerated epithelium-off and accelerated epithelium-on corneal collagen crosslinking in patients with keratoconus. It would be conducted at Guru Nanak Eye Centre, comprising 2 groups of 25 patients per group. The primary outcome is to observe the change in maximum keratometry (Kmax) at 6 months and the secondary objective is to observe the demarcation line on anterior segment OCT at 1 month, change in best corrected visual acuity (BCVA) at 6 months and endothelial cell density at 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Central corneal thickness more than 400 microns at the thinnest point.
排除标准
- •a)Patients with history of trauma and prior ocular surgery b)Corneal scar or history of herpetic keratitis c)Active vernal keratoconjunctivitis.
结局指标
主要结局
1)Change in maximum keratometry (Kmax) at 6 months
时间窗: 6 months
次要结局
- 1)Demarcation line on anterior segment OCT at 1 month(2)Change in best corrected visual acuity (BCVA) at 6months)
研究者
Dr Parul Jain
Department of Ophthalmology Maulana Azad Medical College And associated G.N.E.C
研究点 (1)
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