A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity
研究概览
简要总结
43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern.
All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.
Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Willingness to follow all instructions and comply with schedule for follow up visits
- •Having myopia with manifest refraction spherical equivalent of -1.00 to -2.50 D, with cylindrical component pl to -0.75 D
- •Social security insurance or equivalent
排除标准
- •sensitivity to the use of the test article(s)
- •hypersensitivity to local anesthesics
- •Corneal pachymetry that is < 480 microns
- •Eyes with keratoconus
- •Eyes which are aphakic or with corneal intacs
- •Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: History of corneal disease (e.g., herpes simplex, recurrent erosion syndrome, corneal dystrophy, refractive keratotomy etc.), clinically significant corneal scarring in the crosslinking treatment zone
- •Pregnancy or lactation
- •Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing
- •Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- •Juridical protection
研究组 & 干预措施
Corneal cross linking (CXL)
Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to Ultraviolet A light with the KXL II system according to the programmed treatment pattern.
干预措施: CXL Myopia (Device)
结局指标
主要结局
Best corrected visual acuity
时间窗: 24 months
次要结局
- Adverse events(24 months)
- Uncorrected visual acuity(3 months)
- Mean change in corneal curvature from baseline(3 months)
- Mean change in manifest refraction spherical equivalent from baseline(3 months)