Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Change in Maximum Keratometry From Baseline to 6 Months After Treatment
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.
详细描述
The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years of age or older
- •Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:
- •An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
- •An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
- •A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- •Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
- •Subjects with keratoconus diagnosis only:
- •a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
- •Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
- •Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
- •Signed written informed consent
排除标准
- •Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.
- •Patients with excessively thin corneas.
- •Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
- •a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone
- •A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
- •A known sensitivity to treatment medications.
- •Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
- •Pregnancy (including plan to become pregnant) or lactation during the course of the study
研究组 & 干预措施
Riboflavin 0.1% eyedrops every 5 minutes
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
干预措施: Riboflavin (Drug)
Riboflavin 0.1% eyedrops every 5 minutes
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
干预措施: UVX light (Device)
Riboflavin 0.1% eyedrops every 2 minutes
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
干预措施: Riboflavin (Drug)
Riboflavin 0.1% eyedrops every 2 minutes
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
干预措施: UVX light (Device)
结局指标
主要结局
Change in Maximum Keratometry From Baseline to 6 Months After Treatment
时间窗: 6 months
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
次要结局
- Corrected Distance Visual Acuity (CDVA)(6 months)
- Uncorrected Distance Visual Acuity (UDVA)(6 months)
- Pachymetry(6 months)