Registry to evaluate the long-term effects of corneal cross-linking in patients with corneal ectasia after eye surgery
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
This study is testing how well corneal cross-linking treatment works and how safe it is for people with corneal ectasia after eye surgery over a three-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 11 sites (Palo Alto, California and 10 other locations) |
| Trial ID | NCT03319082 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to assess the safety and durability of the treatment effects of corneal collagen cross-linking (CXL) in patients diagnosed with corneal ectasia following refractive surgery. Approximately 200 participants, aged 18 and older, will be enrolled and monitored for up to three years after their CXL treatment using Photrexa Viscous and Photrexa solutions. Follow-up assessments will occur at 3, 6, 12, 24, and 36 months post-treatment to evaluate both safety and effectiveness outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of corneal ectasia following refractive surgery who are planning to undergo or have recently undergone CXL treatment.
Not a fit: Patients who are pregnant, nursing, or have not undergone CXL treatment within the specified timeframe may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of CXL for patients with corneal ectasia, potentially improving treatment protocols.
How similar studies have performed: Other studies have shown promising results with corneal cross-linking, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Palo Alto, California and 10 other locations
- Stanford University School of Medicine — Palo Alto, California, United States (Recruiting)
- Chu Vision Institute, P.A. — Bloomington, Minnesota, United States (Recruiting)
- Vance Thompson Vision - MT — Bozeman, Montana, United States (Recruiting)
- Vance Thompson Vision - ND — W. Fargo, North Dakota, United States (Recruiting)
- Comprehensive EyeCare of Central Ohio — Westerville, Ohio, United States (Recruiting)
- Vantage Eye Care, LLC — Bala-Cynwyd, Pennsylvania, United States (Recruiting)
- Carolina Cataract & Laser Center — Ladson, South Carolina, United States (Recruiting)
- Slade & Baker Vision — Houston, Texas, United States (Recruiting)
- Hoopes Vision — Draper, Utah, United States (Recruiting)
- See Clearly Vision Group — McLean, Virginia, United States (Recruiting)
- Northwest Eye Surgeons — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Kerry Stephens, OD
- Email: kstephens@glaukos.com
- Phone: 949-481-8057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.