Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Cxlusa
- 入组人数
- 2,228
- 试验地点
- 18
- 主要终点
- Change From Baseline in Corrected Distance Visual Acuity (CDVA)
研究概览
简要总结
This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.
详细描述
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.
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
- Single (Outcomes Assessor)
盲法说明
Visual acuity will be evaluated by an observer who is masked as to the treatment protocol to which study subjects have been assigned.
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of at least one of the following conditions:
- •Keratoconus
- •Forme fruste keratoconus
- •Post-LASIK ectasia
- •Pellucid marginal degeneration
- •Forme fruste pellucid marginal degeneration
- •Diurnal fluctuation post-radial keratotomy
- •Terrien's marginal degeneration
排除标准
- •Corneal thickness < 375 microns measured by ultrasound or Pentacam.
- •Contraindications or hypersensitivities to any study medications or their components.
- •Pregnancy or breastfeeding.
- •Any history of herpes simplex corneal disease in an eye to be treated.
- •Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
- •Inability to cooperate with diagnostic tests.
- •Enrollment in another ophthalmic clinical trial.
结局指标
主要结局
Change From Baseline in Corrected Distance Visual Acuity (CDVA)
时间窗: Baseline and 6 and 12 months
Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline
次要结局
- Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)(Baseline and 6 and 12 months)
- Change From Baseline in Maximum Keratometry (KMax)(Baseline and 6 and 12 months)