Status:
RECRUITING
Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery
Lead Sponsor:
Glaukos Corporation
Conditions:
Corneal Ectasia
Eligibility:
All Genders
18+ years
Brief Summary
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'- phosphat...
Detailed Description
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 informat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03319082
Start Date
October 4 2017
End Date
February 1 2026
Last Update
February 23 2024
Active Locations (11)
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1
Stanford University School of Medicine
Palo Alto, California, United States, 94303
2
Chu Vision Institute, P.A.
Bloomington, Minnesota, United States, 55420
3
Vance Thompson Vision - MT
Bozeman, Montana, United States, 59718
4
Vance Thompson Vision - ND
West Fargo, North Dakota, United States, 58078