Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery

Launched by GLAUKOS CORPORATION · Oct 20, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a treatment called corneal collagen cross-linking in patients who have developed a condition known as corneal ectasia after having eye surgery like LASIK or PRK. The goal is to see how safe this treatment is and how well it works over a period of up to three years. Participants will receive a specific solution (Photrexa Viscous or Photrexa) and use a special device (the KXL System) during their treatment.

To be eligible for this study, participants need to be at least 18 years old and have been diagnosed with corneal ectasia after their eye surgery. They should be willing to follow the study's schedule and provide consent for participation. Women who could become pregnant will need to take a pregnancy test before enrolling. If you join this study, you can expect regular check-ups to monitor your progress and any effects of the treatment over time. It's important to know that the study is currently recruiting participants and is open to everyone regardless of gender.

Gender

ALL

Eligibility criteria

• 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.