Epithelium-on Customized Cross-linking for Keratoconus
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Spectacle-corrected distance visual acuity
研究概览
简要总结
Customized remodeled vision (CuRV) is a new corneal cross-linking protocol for keratoconus, combining a transepithelial approach with customized energy application. Our aim is to follow-up our patients and establish the short-and long-term results of CuRV.
详细描述
Customized remodeled vision is a protocol for oxygen-boosted, tranespithelial cross-linking, customized to apply higher energy at the apex of the cone, relatively lower to the cone area and none to healthy cornea. Thus CuRV promises to halt keratoconus progression, simultaneously offering potential for relatively good visual rehabilitation.Our primary outcomes involve spectacle-corrected distance visual acuity and changes in corneal topography/tomography and OCT parameters. These parameters include Kmax, thinnest corneal pachymetry, maximal anterior and posterior elevation, the Fourier analysis-derived irregularity index, and demarcation line depth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Topographic evidence of keratoconus:
- •maximum corneal curvature (Kmax) ≥47.00 D,
- •localized steepening on topographic maps,
- •localized elevation in the anterior and posterior corneal surfaces.
排除标准
- •Hypersensitivity to riboflavin
- •Thinnest corneal pachymetry < 380 μm
- •History of corneal surgery, including previous cross-linking
- •Corneal scarring
- •Pseudophakia
- •Any visually significant ocular condition
结局指标
主要结局
Spectacle-corrected distance visual acuity
时间窗: 1-3-6 months, 1 year, 2 years
Measurements will be performed on Early Treatment of Diabetic Retinopathy Study charts in logMAR units
Kmax
时间窗: 1-3-6 months, 1 year, 2 years
Maximal corneal keratometric value measured on Scheimpflung corneal tomography
次要结局
- Maximal anterior & posterior elevation(1-3-6 months, 1 year, 2 years)
- Demarcation line depth(1 month)
- Thinnest corneal pachymetry(1-3-6 months, 1 year, 2 years)
- Fourier analysis-calculated maximum decentration(1-3-6 months, 1 year, 2 years)
- Regularization index(1-3-6 months, 1 year, 2 years)