Open Label, Multi-center, Phase I Study of TECLens Corneal Crosslinking System for Correction of Refractive Error in Patients of Presbyopia Age.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Reduce refractive error
研究概览
简要总结
An 'on-eye' UV delivery system for corneal crosslinking can be used safely and effectively to help free presbyopic patients from the need for reading glasses.
详细描述
The clinical trial is evaluating the TECLens CXLens Crosslinking System, an investigational treatment using ultraviolet (UV) light (375 nm) with riboflavin (vitamin B2) to strengthen and reshape the cornea. By creating controlled biomechanical changes, this study aims to test whether the cornea can be reshaped to reduce refractive errors such as mild myopia or hyperopia in patients of presbyopic age.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40-65 years
- •Healthy cornea
- •Refractive error between +4.0 D and -5.0 D
- •Phakic or monofocal pseudophakic (≥6 months post IOL placement)
- •Visual acuity correctable by ±0.25 D
排除标准
- •Corneal dystrophy, scarring, or prior corneal crosslinking
- •Astigmatism >1.0 D
- •Active ocular infection, inflammation, or uncontrolled dry eye
- •Advanced glaucoma or diabetic retinopathy
- •History of delayed corneal healing
- •Pregnancy, breastfeeding, or planning pregnancy during study period
- •Certain medications (e.g., isotretinoin)
- •Recent participation in other investigational drug/device studies (within 30 days)
- •Patients with uncontrolled dry eye or surface disease
结局指标
主要结局
Reduce refractive error
时间窗: 3-months post procedure
Achieve manifest refraction outcome at 3 months post treatment within 0.75D of the pre-planned targeted refraction, in patients aged 40 to 65 years old
次要结局
未报告次要终点