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

ACP-KXL-401

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.

2017-10-04

2026-02-01

2026-02-01

Recruiting

200

Inclusion Criteria: 1. Be at least 18 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form; 3. Willingness and ability to follow all instructions and comply with schedule for study visits; 4. Have a diagnosis of corneal ectasia post-refractive surgery (such as LASIK, PRK); 5. 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); 6. 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. Exclusion Criteria: 1. If female, be pregnant, nursing, or have a positive urine pregnancy test prior to enrollment in the registry; 2. The Investigator may exclude or discontinue any patient for any sound medical reason.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '36 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-02-23