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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 30, 2020

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

Interventions

  • 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.

Arms, Groups and Cohorts

  • Active Comparator: Cross-linking
    • Corneal collagen cross-linking with riboflavin and UVA light
  • Active Comparator: Cross-linking plus INTACS
    • Corneal collagen cross-linking with riboflavin and UVA light plus INTACS

Clinical Trial Outcome Measures

Primary Measures

  • Effectiveness of UV-X cross linking to halt progression of keratoconus
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • progressive keratoconus or ectasia Exclusion Criteria:

  • cornea thinner than 400um – K readings greater than 60D – Central corneal scarring

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yaron S. Rabinowitz M.D.
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Yaron S. Rabinowitz M.D., Yaron S Rabinowitz M.D. – Cornea Genetic Eye Institute
  • Overall Official(s)
    • Yaron S Rabinowitz, M.D., Principal Investigator, Cornea Genetic Eye Institute
    • Ezra Maguen, M.D., Principal Investigator, american eye institute
    • Yuri Oleynikov, M.D. PhD, Principal Investigator, Cornea Genetic Eye Institute
    • James Salz, M.D., Principal Investigator, Laser Eye Associates
    • Ronald Gaster, MD, Principal Investigator, Cornea Eye Institute, Beverly Hills

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