Observational Registry to Assess the Durability of Effect of CXL in Patients With Corneal Ectasia After Refractive Surgery
CXL
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
1 other identifier
observational
200
1 country
11
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'- phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'- phosphate ophthalmic solution), and the KXL System in patients with corneal ectasia following refractive surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2017
CompletedFirst Submitted
Initial submission to the registry
October 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedFebruary 23, 2024
February 1, 2024
8.3 years
October 20, 2017
February 22, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Kmax
Change from pretreatment baseline in maximum corneal curvature
36 months
BCVA
Change from pretreatment baseline in BCVA
36 month
Study Arms (1)
CXL Group
Patients with corneal ectasia following refractive surgery who had corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information
Interventions
Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation).
Eligibility Criteria
Patients with corneal ectasia following refractive surgery who are planning to undergo or have undergone corneal collagen cross-linking in one or both eyes according to the Photrexa Viscous and Photrexa prescribing information.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford University School of Medicine
Palo Alto, California, 94303, United States
Chu Vision Institute, P.A.
Bloomington, Minnesota, 55420, United States
Vance Thompson Vision - MT
Bozeman, Montana, 59718, United States
Vance Thompson Vision - ND
West Fargo, North Dakota, 58078, United States
Comprehensive EyeCare of Central Ohio
Westerville, Ohio, 43082, United States
Vantage Eye Care, LLC
Bala-Cynwyd, Pennsylvania, 19004, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456, United States
Slade & Baker Vision
Houston, Texas, 77027, United States
Hoopes Vision
Draper, Utah, 84020, United States
See Clearly Vision Group
McLean, Virginia, 22102, United States
Northwest Eye Surgeons
Seattle, Washington, 98133, United States
Related Publications (1)
Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484. doi: 10.1016/j.ophtha.2017.05.036. Epub 2017 Jun 24.
PMID: 28655538BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kerry Stephens
Glaukos Corporation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 36 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2017
First Posted
October 24, 2017
Study Start
October 4, 2017
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
February 23, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share