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

    Phase 3
  • Study Type

  • Intervention/Treatment

    ribavirin ...
  • Study Participants

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.
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 Started
Dec 31
Primary Completion
Nov 30
Study Completion
Nov 30
Results Posted
Jan 27
Last Update
Apr 26

Drug riboflavin ophthalmic solution

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

Device UVA Irradiation

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

  • Other names: UV-X™ Illumination System

Corneal Collagen Cross-linking (CXL) Treatment Group Active Comparator

riboflavin ophthalmic solution and UVA irradiation

Control Group Sham Comparator

riboflavin opthalmic solution without UVA irradiation


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


Control Group

Corneal Collagen Cross-linking (CXL) Treatment Group

All Events

Event Type Organ System Event Term Corneal Collagen Cross-linking (CXL) Treatment Group Control Group

Mean Change From Baseline in Maximum Keratometry (Kmax)

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.

Corneal Collagen Cross-linking (CXL) Treatment Group

diopters (Mean)
Standard Deviation: 2.2

Control Group

diopters (Mean)
Standard Deviation: 2.3





Age, Categorical

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Sex: Female, Male

Overall Study

Corneal Collagen Cross-linking (CXL) Treatment Group

Control Group

Drop/Withdrawal Reasons

Corneal Collagen Cross-linking (CXL) Treatment Group

Control Group