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

Sponsor
Cxlusa (Industry)
Overall Status
Terminated
CT.gov ID
NCT01097447
Collaborator
(none)
2,619
5
88.9
523.8
5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2619 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
    Actual Study Start Date :
    Dec 1, 2009
    Actual Primary Completion Date :
    Apr 30, 2017
    Actual Study Completion Date :
    Apr 30, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [1 year]

    Secondary Outcome Measures

    1. increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clear View Eye & Laser Medical Center San Diego California United States 92121
    2 Corneal Consultants of Colorado, P.C Littleton Colorado United States
    3 Chicago Cornea Consultants, LTD Hoffman Estates Illinois United States
    4 Minnesota Eye Consultants, P.A. Bloomington Minnesota United States 55431
    5 Cornea Associates of Texas Dallas Texas United States 75231

    Sponsors and Collaborators

    • Cxlusa

    Investigators

    • Principal Investigator: Parag Majmudar, MD, Chicago Cornea Consultants, LTD
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cxlusa
    ClinicalTrials.gov Identifier:
    NCT01097447
    Other Study ID Numbers:
    • CXL (2)
    First Posted:
    Apr 1, 2010
    Last Update Posted:
    Oct 11, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Cxlusa
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 11, 2018