Skip to main content
OpenTrials
Completed

NCT Number: NCT00647699

Corneal Collagen Cross-linking for Progressive Keratoconus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Progressive Keratoconus Corneal Diseases Eye Diseases Keratoconus

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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

  1. 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 Progressive Keratoconus

Acronym: CXL

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 1, 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.

Related clinical trials

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