Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

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

Study Overview

• Status: Terminated
• Conditions: Keratoconus; Ectasia; Degeneration

• Study Type: Observational
• Enrollment (Actual): 2619

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Clear View Eye & Laser Medical Center
  • Colorado
    • Littleton, Colorado, United States
      • Corneal Consultants of Colorado, P.C
  • Illinois
    • Hoffman Estates, Illinois, United States
      • Chicago Cornea Consultants, LTD
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants, P.A.
  • Texas
    • Dallas, Texas, United States, 75231
      • Cornea Associates of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

• 8 years of age or older
• Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
• 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

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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Ciprofloxicine or Vigamox or other; up to qid till epithelialized.
Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom; up to qid for up to 5-10 days postop
Topical steroid (FML, Pred Forte, Flarex; qid for up to 8 weeks

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	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	1 year

Collaborators and Investigators

• Sponsor: Cxlusa
• Investigators: Principal Investigator: Lance Forstot, MD, Corneal Consultants of Colorado, P.C; Principal Investigator: Bradley Bowman, M.D, Cornea Associates of Texas; Principal Investigator: Sandy Feldman, M.D, Clear View Eye & Laser Medical Center; Principal Investigator: Sherman Reeves, MD, Minnesota Eye Consultants, P.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2009
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): April 30, 2017

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (ESTIMATE): April 1, 2010

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Corneal Diseases; Keratoconus; Dilatation, Pathologic
• Other Study ID Numbers: CXL (2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO