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

Status unconfirmed

Conditions studied: Corneal Ectasia

In brief

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.

Key facts

Study ID

NCT03319082

Run by

Glaukos Corporation

People needed

200

Starts

2017-10-04

Expected to finish

2026-02-01

Last updated by the study team

2024-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Palo Alto, California, United States (enrolling)
• Chu Vision Institute, P.A. — Bloomington, Minnesota, United States (enrolling)
• Vance Thompson Vision - MT — Bozeman, Montana, United States (enrolling)
• Vance Thompson Vision - ND — West Fargo, North Dakota, United States (enrolling)
• Comprehensive EyeCare of Central Ohio — Westerville, Ohio, United States (enrolling)
• Vantage Eye Care, LLC — Bala-Cynwyd, Pennsylvania, United States (enrolling)
• Carolina Cataract & Laser Center — Ladson, South Carolina, United States (enrolling)
• Slade & Baker Vision — Houston, Texas, United States (enrolling)
• Hoopes Vision — Draper, Utah, United States (enrolling)
• See Clearly Vision Group — McLean, Virginia, United States (enrolling)
• Northwest Eye Surgeons — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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