Corneal Collagen Cross-linking for Progressive Keratoconus
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
  • Phase

    Phase 3
  • Study Type

  • Intervention/Treatment

    ribavirin ...
  • Study Participants

Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.
Study Started
Dec 31
Primary Completion
Apr 30
Study Completion
Apr 30
Results Posted
Jul 07
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 ophthalmic solution without UVA irradiation.


Inclusion Criteria:

Diagnosis of keratoconus
Documented progression over previous 24 months
Decreased BSCVA
Must complete all study visits

Exclusion Criteria:

Prior corneal surgery or Intacs
History of delayed wound healing


Corneal Collagen Cross-linking (CXL) Treatment Group

Control 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: 4.7

Control Group

diopters (Mean)
Standard Deviation: 2.8



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