Corneal Collagen Cross-Linking for Ectasia (CXL)

Phase 3

Completed

• Conditions: Ectasia
• Interventions: Drug: riboflavin ophthalmic solution; Device: UVA Irradiation

• Registration Number: NCT00674661
• Lead Sponsor: Glaukos Corporation

Brief Summary

Prospective, randomized multicenter study to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes with ectasia after refractive surgery.

Detailed Description

Subjects are randomized to a control group or a treatment group, with the control group crossed over to the treatment group at the 3 month visit. Corneal collagen cross-linking is performed as a single treatment. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-08
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Disposition First Submitted: 2012-05-18
• Disposition First Submitted QC: 2012-05-18
• Disposition First Posted: 2012-05-30
• Results First Submitted: 2016-08-17
• Results First Submitted QC: 2016-12-02
• Results First Posted: 2017-01-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-22
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Diagnosis of ectasia after refractive surgery
• Documented ectasia on Pentacam or topography map
• BSCVA worse than 20/20
• Must complete all study visits

Exclusion Criteria

• History of delayed wound healing
• History of corneal melt or corneal dystrophy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal Collagen Cross-linking (CXL) Treatment Group	riboflavin ophthalmic solution	riboflavin ophthalmic solution and UVA irradiation
Corneal Collagen Cross-linking (CXL) Treatment Group	UVA Irradiation	riboflavin ophthalmic solution and UVA irradiation
Control Group	riboflavin ophthalmic solution	riboflavin opthalmic solution without UVA irradiation

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Maximum Keratometry (Kmax)	baseline,12 months	The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.

Trial Locations

Locations (10)

Gordon -Weiss Vision Institute; 🇺🇸 San Diego, California, United States

Edward Harkness Eye Institute at Columbia University Medical Center; 🇺🇸 New York, New York, United States

Shiley Eye Center; 🇺🇸 La Jolla, California, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Wilmer Eye Institute at Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Rockville Centre, New York, United States

Durrie Vision; 🇺🇸 Kansas City, Kansas, United States

Cornea & Laser Eye Institute; Hersh Vision Group; 🇺🇸 Teaneck, New Jersey, United States

Minnesota Eye Consultants; 🇺🇸 Minneapolis, Minnesota, United States