Comparison of Epithelium-on CuRV and Epithelium-off aCXL Protocols in the Management of Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 主要终点
- Change in Maximal Corneal Curvature Keratometry Kmax
研究概览
简要总结
This study investigates the effectiveness and safety of two different corneal cross-linking (CXL) protocols for the management of progressive keratoconus: the accelerated epithelium-off technique (aCXL) and the topography-guided epithelium-on Customized Remodeled Vision (CuRV) protocol. These methods differ in their mode of ultraviolet-A (UVA) energy delivery and their approach to corneal surface preservation, with potential implications for both structural stabilization and patient comfort. The primary aim was to evaluate changes in corrected distance visual acuity (CDVA) and maximum keratometry (Kmax) over a 24-month follow-up period, allowing for a direct comparison of visual and topographic outcomes between the two approaches.
By assessing these endpoints, the study seeks to address whether epithelium-on, customized cross-linking can achieve similar or improved results compared with conventional accelerated epithelium-off treatment. The findings are intended to provide insights into the relative benefits of standardized versus individualized cross-linking techniques, with the broader goal of optimizing treatment strategies for patients with keratoconus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult eyes
- •progressive keratoconus (grades 1 to 3-4, Krumeich-Amsler classification)
- •corneal thickness ≥400 μm
- •endothelial cell density ≥1500 cells/mm²
排除标准
- •prior corneal surgeries
- •corneal scars
- •dystrophies
- •marginal pellucid degeneration
- •systemic connective tissue disorders
- •uncontrolled diabetes
- •pregnancy, or breastfeeding.
结局指标
主要结局
Change in Maximal Corneal Curvature Keratometry Kmax
时间窗: Baseline, 1 Month, 6 Months, 1 Year, 2 Years
The difference in Kmax values measured between baseline and subsequent follow-up visits
次要结局
- Change in Manifest refraction Spherical Equivalent(Baseline, 1 Month, 6 Months, 1 Year, 2 Years)
- Change in Uncorrected Distance Visual Acuity(Baseline, 1 Month, 6 Months, 1 Year, 2 Years)
- Change in Mean Corneal Curvature Keratometry Kmean(Baseline, 1 Month, 6 Months, 1 Year, 2 Years)
- Change in Corrected Distance Visual Acuity(Baseline, 1 Month, 6 Months, 1 Year, 2 Years)
- Change in Thinnest Corneal Thickness(Baseline, 1 Month, 6 Months, 1 Year, 2 Years)
研究者
Dr. Pavel Stodulka
Principal Investigator
Gemini Eye Clinic