Corneal Crosslinking in Keratoconus and Corneal Ectasia (CXL)

April 18, 2017 updated by: Ohio State University

Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia

Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
      • Dublin, Ohio, United States, 43016
        • OSU Havener Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of keratoconus with documented progression over the previous 12 months.
  • Diagnosis of corneal ectasia
  • Must be able to complete all study visits.

Exclusion Criteria:

  • Prior corneal surgery in keratoconus group
  • Corneal scarring
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham treatment
Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit.
Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
Active Comparator: Treatment Arm
After randomization, the active arm will have the collagen crosslinking intervention.
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
Other Names:
  • Vitamin B2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in keratometry
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
best spectacle-corrected visual acuity
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Keates, MD, The Ohio State Univesity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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