Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Cxlusa
Information provided by (Responsible Party):
Cxlusa Identifier:
First received: September 27, 2013
Last updated: February 1, 2017
Last verified: August 2015
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.

Condition Intervention Phase
Other: Theralight crosslinking and Riboflavin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Resource links provided by NLM:

Further study details as provided by Cxlusa:

Primary Outcome Measures:
  • Change in Best Spectacle Corrected Visual Acuity (BSCVA) [ Time Frame: 6-9 months ]

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

Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01956474

Contact: Debi Graveman 314 966-3377

United States, Florida
Center for Excellence in Eye Care Recruiting
Miami, Florida, United States, 33176
Contact: Matty Infante   
Sub-Investigator: William Trattler, MD         
United States, Georgia
Stulting Research Center at Woolfson Eye Institute Recruiting
Atlanta, Georgia, United States, 30328
Contact: Debbie Dichiara   
Principal Investigator: Robert Stulting, MD         
United States, Maryland
TLC Laser Eye Center Recruiting
Rockville, Maryland, United States, 20852
Contact: Stephanie Merritt   
Principal Investigator: Levy Marc, OD         
United States, Massachusetts
Talamo Hatch Laser Eye Consultants, LLC Recruiting
Boston, Massachusetts, United States, 02451
Contact: Migdali Rivera   
Principal Investigator: Johnathan Talamo, MD         
United States, Ohio
Cleveland Eye Clinic Recruiting
Brecksville, Ohio, United States, 44141
Contact: Karen Keaton   
Principal Investigator: Shamik Bafna, MD         
United States, Virginia
TLC Laser Eye Center Recruiting
Fairfax, Virginia, United States, 22031
Contact: Stephanie Merritt   
Principal Investigator: Marc Levy, OD         
Sponsors and Collaborators
Principal Investigator: William Trattler, MD Cxlusa
  More Information

Responsible Party: Cxlusa Identifier: NCT01956474     History of Changes
Other Study ID Numbers: CXL-04
Study First Received: September 27, 2013
Last Updated: February 1, 2017

Keywords provided by Cxlusa:
Post-LASIK ectasia
Pellucid marginal degeneration
Forme fruste pellucid marginal degeneration
Radial Keratotomy
Terrien's Marginal Degeneration

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents processed this record on May 23, 2017