To Compare the Outcomes of Accelerated Transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS) in patients with progressive Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Demarcation line depth and visibility to be measured on Swept source OCT at 8 weeks after the CXL procedure
研究概览
简要总结
To compare the outcomes of accelerated transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl polyethylene glycol succinate(TPGS) in patients with progressive keratoconus. Considering the potential benefits of transepithelial CXL, the reduced time taken by
accelerated CXL without compromising the efficacy and the potency of vitamin E-TPGS
riboflavin to effectively enhance riboflavin penetration, this study aims to evaluate the
outcome of vitamin E-TPGS riboflavin in patients with progressive keratoconus.
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
- 18.00 Month(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18 years or above
- •Thinnest pachymetry of 360 micrometer or above on Pentacam
- •K-max of 65D or less onScheimpflug imaging with Pentacam
- •Grade 1-3 keratoconus by Belin ABCD classification on Pentacam.
- •Corrected distance visual acuity (CDVA) of less than 20/20 on the Snellen vision chart
- •Endothelial cell density of 2000 cells/mm2 or above
- •Absence of any ocular surface disorders and other active ocular allergic conditions.
排除标准
- •Presence of advanced keratoconus associated with subepithelial scarring
- •History of herpetic keratitis or recurrent corneal erosions
- •Previous corneal surgery
- •Previous history of cross linking
- •Patients who are pregnant or breast feeding.
- •Patients with autoimmune diseases.
结局指标
主要结局
Demarcation line depth and visibility to be measured on Swept source OCT at 8 weeks after the CXL procedure
时间窗: 8 weeks after the CXL procedure
procedure
时间窗: 8 weeks after the CXL procedure
次要结局
- 1. Change in total corneal densitometry at 3 months & 6 months post CXL compared(to pre CXL values)
- 2. Change in maximum keratometry(Kmax) 3 months & 6 months after CXL(compared to pre CXL values)
- 3. Change in total corneal Higher order aberrations at 3 months & 6 months(3 months & 6 months)
研究者
Dr Poppy Debbarma
Post Graduate Institute of Medical Education and Research