Corneal Collagen Cross-Linking for Ectasia (CXL)

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.

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Key information

Conditions

Ectasia Corneal Diseases Dilatation, Pathologic Eye Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shiley Eye Center, La Jolla, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

riboflavin ophthalmic solution

Drug

riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)

UVA Irradiation

Device

UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes

Other names: UV-X™ Illumination System

Primary outcomes

Mean Change From Baseline in Maximum Keratometry (Kmax)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Glaukos Corporation

Industry

Registry information

Official study title

Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery

Acronym: CXL

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: May 8, 2008
Registry last updated: Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed