CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

October 10, 2018 updated by: Cxlusa

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.

Study Type

Interventional

Enrollment (Actual)

1324

Phase

  • Phase 2

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

  • United States
    • Florida
      • Miami, Florida, United States, 33176
        • Center for Excellence in Eye Care
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Stulting Research Center at Woolfson Eye Institute
    • Maryland
      • Rockville, Maryland, United States, 20852
        • TLC Laser Eye Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02451
        • Talamo Hatch Laser Eye Consultants, LLC
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • TLC Laser Eye Center

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 8 years of age or older

  2. Having at least one of the following conditions:

    • Keratoconus
    • Post-LASIK ectasia
    • Pellucid marginal degeneration
    • Forme fruste pellucid marginal degeneration
    • FFKC
    • History of Radial Keratotomy with fluctuating vision.
    • Terrien's Marginal Degeneration
  3. Signed written informed consent and/or assent
  4. Likely to complete all study visits
  5. Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria:

  1. Severe corneal scarring that markedly affects vision
  2. Contraindications to any study medications or their components
  3. Pregnancy or breast feeding
  4. Active Herpes Corneal Disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Theralight crosslinking and Riboflavin
ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin
Other: Theralight crosslinking and Riboflavin
Corneal Collagen cross linking with UV light and riboflavin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Best Spectacle Corrected Visual Acuity (BSCVA)
Time Frame: 6-9 months
6-9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Uncorrected Visual Acuity (UCVA)
Time Frame: 6-9 months
6-9 months
Change in Corneal topography
Time Frame: 6-9 months
6-9 months
Change in Manifest Refraction
Time Frame: 6-9 months
6-9 months
Change in Keratometry on topography and Pentacam
Time Frame: 6-9 months
6-9 months
Change in Wavefront Refraction and aberrations
Time Frame: 6-9 months
6-9 months

Collaborators and Investigators

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

Sponsor

Cxlusa

Investigators

  • Principal Investigator: William Trattler, MD, Cxlusa

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

January 1, 2013

Primary Completion (Actual)

February 3, 2017

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 4, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-04

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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