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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Cxlusa
Sponsor:
Information provided by (Responsible Party):
Cxlusa
ClinicalTrials.gov Identifier:
NCT01956474
First received: September 27, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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
Keratoconus
Device: Theralight crosslinking and Riboflavin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Uncorrected Visual Acuity (UCVA) [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
  • Change in Corneal topography [ Time Frame: 6-9 months ] [ Designated as safety issue: Yes ]
  • Change in Manifest Refraction [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
  • Change in Keratometry on topography and Pentacam [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
  • Change in Wavefront Refraction and aberrations [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corneal Cross-linking
ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin
Device: Theralight crosslinking and Riboflavin

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01956474

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

No publications provided

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01956474     History of Changes
Other Study ID Numbers: CXL-04
Study First Received: September 27, 2013
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Corneal Diseases
Keratoconus
Eye Diseases
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 20, 2014