A Phase IV Observational Registry to Assess the Safety and Durability of Effect of Corneal Collagen Cross-linking With Photrexa Viscous, Photrexa, and the KXL System in Patients With Corneal Ectasia Following Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Kmax
研究概览
简要总结
The objectives of this post market registry are to evaluate the safety and durability of treatment effect up to 3 years following cross-linking performed with Photrexa Viscous (riboflavin 5'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.
详细描述
Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Be at least 18 years of age, male or female, of any race;
- •Provide written informed consent and sign a HIPAA form;
- •Willingness and ability to follow all instructions and comply with schedule for study visits;
- •Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK);
- •Planning to undergo (or have undergone within the past 90 days) corneal collagen cross-linking with PHOTREXA VISCOUS/ PHOTREXA and the KXL System, per the prescribing information (NOTE: Complete treatment and follow-up data, including any product-related events at time of procedure through the time of enrollment must be available);
- •For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to enrolling in the registry; must not be pregnant or lactating.
排除标准
- •If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry;
- •The Investigator may exclude or discontinue any patient for any sound medical reason.
结局指标
主要结局
Kmax
时间窗: 36 months
Change from pretreatment baseline in maximum corneal curvature
BCVA
时间窗: 36 month
Change from pretreatment baseline in BCVA
次要结局
未报告次要终点