跳至主要内容
临床试验/CTRI/2024/01/061566
CTRI/2024/01/061566尚未招募不适用

To evaluate the efficacy of collagen cross-linking with individualized fluence (sub 400 protocol) in keratoconus patient with ultrathin cornea.

Dr Parul Jain1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年1月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
试验地点
1
主要终点
Change in maximum keratometry (Kmax)

研究概览

简要总结

Keratoconus is a chronic progressive ophthalmic disease that leads to bulging and thinning of the cornea, resulting in increasing irregular astigmatism and ultimately poor vision. The introduction of collagen cross inking (CXL) has changed the natural course of this disease and as a result reduced the need for corneal transplants.

Corneas with advanced disease that would likely benefit from undergoing CXL cannot be treated with the Dresden protocol because of corneal thickness less than 400 microns. The sub400 protocol approach in ultrathin corneas will broaden the range of indications of CXL and further decrease the need for corneal transplantations.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Cases of keratoconus with epithelium-on corneal stromal thickness of < 400µm.

排除标准

  • Active and severe vernal keratoconjunctivitis/Atopic keratoconjunctivitis
  • Previous keratitis/corneal scars
  • Pregnancy or lactating women
  • Preexisting ocular trauma
  • Previous ocular surgeries.

结局指标

主要结局

Change in maximum keratometry (Kmax)

时间窗: 1 year

次要结局

  • Demarcation line on Anterior Segment OCT (ASOCT)(1 month)
  • Change in Best Corrected Visual Acuity (BCVA)(1 year)
  • Endothelial cell count(1 year)

研究者

发起方
Dr Parul Jain
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Parul Jain

Maulana Azad Medical College

研究点 (1)

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