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

United States200 participantsStarted 2017-10-04

Plain-language 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'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Kmax

Timeframe: 36 months

BCVA

Timeframe: 36 month

Trial details

NCT IDNCT03319082

SponsorGlaukos Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-02

Contact for this trial

Kerry Stephens, OD

949-481-8057 kstephens@glaukos.com

View on ClinicalTrials.gov More Corneal Ectasia trials