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Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs

Sponsor
Yaron S. Rabinowitz M.D. (Other)
Overall Status
Unknown status
CT.gov ID
NCT01081561
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
149.3
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the efficacy of collagen cross linking for progressive keratoconus and ectasia after lasik. It will try and determine which is a more effective treatment: collagen cross linking alone or collagen cross linking combined with Intacs, a treatment which has already been proven to be effective in decreasing corneal curvature in patients with keratoconus.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

In this study we will attempt to determine whether Collagen Cross Linking alone, one combined with insertion of INTACS is the most effective treatment for patients with progressive keratoconus in patients who have progressive disease.

These treatments have been widely used outside of the United States for the treatment of progressive keratoconus. Corneal Collagen Cross linking was recently approved in the United States for the treatment of progressive keratoconus. We will attempt to study 600 patients total. 300 patients will be assigned to cross linking only while another 300 will be assigned to cross linking and INTACS. Once adequate number of study subjects have been recruited data will be analyzed to determine which treatment is more effective. The following parameters from Topography, OCT and Tomography will be studied(these are Max K(pentacam) Kvalue(Tomey Topography)I-Svalue(Tomey Topography Astigmatism(Tomey Topography) and Min OCT(corneal pachymetry) any one of these metrics that achieve a value of 1 or more will be included in the analysis since the cornea is so irregular that values less than one could be artifact

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Study of Corneal Collagen Cross-Linking With the UV-X System for the Treatment of Keratectasia in Eyes With Intacs Compared to Eyes Without Intacs
Actual Study Start Date :
Jan 21, 2009
Anticipated Primary Completion Date :
Dec 30, 2020
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cross-linking

Corneal collagen cross-linking with riboflavin and UVA light

Drug: Riboflavin
Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
Other Names:
  • Peschke Meditrade

    		•
    Active Comparator: Cross-linking plus INTACS

    Corneal collagen cross-linking with riboflavin and UVA light plus INTACS

    Drug: Riboflavin
    Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
    Other Names:
  • Peschke Meditrade

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness of UV-X cross linking to halt progression of keratoconus [10 years]

      Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • progressive keratoconus or ectasia
    Exclusion Criteria:

    • cornea thinner than 400um

    • K readings greater than 60D

    • Central corneal scarring

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cornea Eye Institute, 50 North La Cienaga Blvd, #340 Beverly Hills California United States 90211

    Sponsors and Collaborators

    • Yaron S. Rabinowitz M.D.

    Investigators

    • Principal Investigator: Yaron S Rabinowitz, M.D., Cornea Genetic Eye Institute
    • Principal Investigator: Ezra Maguen, M.D., american eye institute
    • Principal Investigator: Yuri Oleynikov, M.D. PhD, Cornea Genetic Eye Institute
    • Principal Investigator: James Salz, M.D., Laser Eye Associates
    • Principal Investigator: Ronald Gaster, MD, Cornea Eye Institute, Beverly Hills

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yaron S. Rabinowitz M.D., Yaron S Rabinowitz M.D., Cornea Genetic Eye Institute
    ClinicalTrials.gov Identifier:
    NCT01081561
    Other Study ID Numbers:
    • #20090780
    First Posted:
    Mar 5, 2010
    Last Update Posted:
    Oct 2, 2018
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Keratoconus
    Dilatation, Pathologic
    Riboflavin

    Study Results

    No Results Posted as of Oct 2, 2018