NCT06549387尚未招募不适用
Topo-Pachymetric Customized Accelerated Epithelium-On Versus Standard Accelerated Epithelium-Off Corneal Collagen Cross Linking in the Management of Keratoconus
Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2024年8月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Change in the endothelial cell count.
研究概览
简要总结
The objective of this study is to compare the clinical effectiveness and safety of Topo-Pachymetric Customized Accelerated Epithelium-On (aCFXL) to Standard Accelerated Epithelium-Off (aCXL) Corneal Collagen Cross-Linking in the management of keratoconus. The study aims to evaluate visual and structural outcomes, to provide valuable insights into optimizing treatment strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18 years or older
- •Corrected distance visual acuity (CDVA) of ≥ 0.3 Snellen.
- •Central corneal thickness (de-epithelialized) of ≥ 400 micron.
- •Corneal endothelial count of ≥ 2000.
排除标准
- •Previous eye surgery
- •The presence of lesions other than keratoconus, central or paracentral scaring
- •History of Cross linking
- •History of viral keratitis
- •Connective tissue diseases
- •Pregnancy or lactation during the study.
- •The presence of nystagmus
研究组 & 干预措施
The standard accelerated CXL (aCXL) protoco
Active Comparator
干预措施: Corneal cross linking (Procedure)
Progressive Fluence Epi-on accelerated crosslinking M nomogram
Active Comparator
干预措施: Corneal cross linking (Procedure)
The topo-pachimetric customized accelerated epithelium-On (aCFXL group)
Active Comparator
干预措施: Corneal cross linking (Procedure)
结局指标
主要结局
Change in the endothelial cell count.
时间窗: 6 months
the stability or decrease in the endothelial cell count.
Amount of corneal flattening
时间窗: 6 months
Kmax flattening
次要结局
- Best corrected visual acuity(6 months)
研究者
Paula Sameh Youssef
M.Sc.
Kasr El Aini Hospital
研究点 (1)
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