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

Recruiting

• Conditions: Corneal Ectasia
• Interventions: Combination Product: Corneal Collagen Cross-linking

• Registration Number: NCT03319082
• Lead Sponsor: Glaukos Corporation

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.

Detailed 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.

Study Timeline

• Study Start: 2017-10-04
• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-24
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CXL Group	Corneal Collagen Cross-linking	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

Primary Outcome Measures

Name	Time	Method
Kmax	36 months	Change from pretreatment baseline in maximum corneal curvature
BCVA	36 month	Change from pretreatment baseline in BCVA

Trial Locations

Locations (11)

Carolina Cataract & Laser Center; 🇺🇸 Ladson, South Carolina, United States

Slade & Baker Vision; 🇺🇸 Houston, Texas, United States

Northwest Eye Surgeons; 🇺🇸 Seattle, Washington, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Vance Thompson Vision - ND; 🇺🇸 W. Fargo, North Dakota, United States

Comprehensive EyeCare of Central Ohio; 🇺🇸 Westerville, Ohio, United States

Vantage Eye Care, LLC; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

Hoopes Vision; 🇺🇸 Draper, Utah, United States

See Clearly Vision Group; 🇺🇸 McLean, Virginia, United States

Vance Thompson Vision - MT; 🇺🇸 Bozeman, Montana, United States

Chu Vision Institute, P.A.; 🇺🇸 Bloomington, Minnesota, United States