Cross-linking of Corneal Collagen (CXL) 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. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.

Study Overview

Study Type

Observational

Enrollment (Actual)

3493

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

    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Schwartz Laser Eye Center
    • California
      • Laguna Hills, California, United States
        • Harvard Eye Associates
      • San Diego, California, United States
        • Clear View Eye & Laser Medical Center
      • San Francisco, California, United States
      • West Hills, California, United States
        • Davidorf Eye Group
    • Colorado
      • Littleton, Colorado, United States
        • Corneal Consultants of Colorado, P.C
    • Florida
      • Miami, Florida, United States, 33176
        • The Center for Excellence in Eye Care
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Chicago Cornea Consultants, LTD
    • Maryland
      • Rockville, Maryland, United States, 20852
        • TLC Laser Eye Center
    • Massachusetts
      • Waltham, Massachusetts, United States
        • Talamo Laser Eye Center
    • Missouri
      • Saint Louis, Missouri, United States
        • Ophthalomology Associates
    • New York
      • Wantagh, New York, United States, 11793
        • South Shore Eye Care LLP
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • TLC Laser Eye Center
    • Washington
      • Seattle, Washington, United States
        • Northwest Eye Surgeons
      • Spokane Valley, Washington, United States
        • Empire Eye Physicians

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Primary care clinic.

Description

Inclusion Criteria:

  • 12 years of age or older
  • Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
  • Diagnosis of FFKC
  • History of Radial Keratotomy with fluctuating vision
  • Ability to provide written informed consent
  • Likely to complete all study visits
  • Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam
  • At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

Exclusion Criteria:

  • Severe corneal scarring that markedly affects vision
  • Contraindications to any study medications or their components
  • Pregnancy or breast feeding
  • 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nonsteroidal (Acular, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.
Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: John Hovanesian, MD, Harvard Eye Associates
  • Principal Investigator: Jodi Luchs, MD, South Shore Eye Care LLP
  • Principal Investigator: Shamik Bafna, MD, Cleveland Eye Clinic
  • Principal Investigator: Jay Schwartz, MD, Schwartz Laser Eye Center
  • Principal Investigator: Jonathan Davidorf, MD, Davidorf Eye Group
  • Principal Investigator: Daniel Goodman, MD, Goodman Eye Center
  • Principal Investigator: Jonathan Talamo, MD, Talamo Laser Eye Center
  • Principal Investigator: Sandy Feldman, MD, Clear View Eye & Laser Medical Center
  • Principal Investigator: Gregg Berdy, MD, Ophthalomology Associates
  • Principal Investigator: Lance Forstot, Corneal Consultants of Colorado, P.C
  • Principal Investigator: Mark Kontos, MD, Empire Eye Physicians
  • Principal Investigator: Audrey Rostov, MD, Northwest Eye Surgeons

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 (Actual)

February 1, 2010

Primary Completion (Actual)

February 3, 2017

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

July 20, 2010

First Submitted That Met QC Criteria

August 25, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

September 1, 2018

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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