NCT07629557招募中4 期
Single-arm, Multi-center Study to Evaluate the Safety and Feasibility of Bilateral Epithelium-on Corneal Collagen Cross-linking With Epioxa™ HD/Epioxa™ and UV-A Irradiation Using the O2n™ System and Supplemental Oxygen Using the Boost Goggles® in Subjects With Keratoconus
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent
- •Willing and able to comply with study instructions and follow-up visits
- •Diagnosis of keratoconus in each eye
排除标准
- •Known allergy or sensitivity to study medications
- •History of corneal disease
- •Prior corneal cross-linking in either eye
- •Pregnant, nursing, or planning pregnancy during the study period
- •Participated in other investigational drug or device trial within 30 days of the study
研究者
研究点 (1)
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