Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- evaluation of depth of demarcation line
研究概览
简要总结
To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients
详细描述
Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •progressive keratoconus stage 1-2
排除标准
- •any concomitant ocular disease
研究组 & 干预措施
Epithelium-off accelerated cross-linking
Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A "UVA" irradiation of 30 mW/cm2 for 4 minutes
干预措施: corneal cross-linking (Procedure)
Transepithelial accelerated cross-linking
Paracel is instilled 1 drop every 1.5 minutes for 4.5 minutes then vibex-xtra is instilled 4 drops at 5.5 minutes followed by 1 drop at 6.5 minutes for a total soak time of 11 minutes followed by ultraviolet-A" UVA" irradiation with intended irradiance of 45mW/cm2 for 2.4 minutes
干预措施: corneal cross-linking (Procedure)
结局指标
主要结局
evaluation of depth of demarcation line
时间窗: 1 month postoperative
Anterior segment optical coherence tomography "AS-OCT" is used to measure depth of demarcation line
次要结局
未报告次要终点
研究者
Sarah Akram Azzam
Principal investigator
Kasr El Aini Hospital