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

Corneal Ectasia Clinical Trial

— CXL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03319082
• Other study ID #: ACP-KXL-401
• Status: Recruiting
• Start date: October 4, 2017
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Glaukos Corporation
• Contact: Kerry Stephens, OD
• Phone: 949-481-8057
• Email: kstephens[@]glaukos.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Approximately 200 patients who are planning to undergo or have undergone CXL for the treatment of corneal ectasia following refractive surgery in one or both eyes according to the prescribing information in the Photrexa Viscous and Photrexa Package Insert could be enrolled. Patients will be followed for safety and effectiveness at Months 3, 6, 12, 24 and 36 following cross-linking treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Diseases
• Corneal Ectasia

Intervention

Combination Product:
• Corneal Collagen Cross-linking
Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kmax	Change from pretreatment baseline in maximum corneal curvature	36 months
Primary	BCVA	Change from pretreatment baseline in BCVA	36 month

External Links

•   U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery