Trial | NCT01081561  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    riboflavin ...

  • Study Participants

    600
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.
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 Started
Jan 21
2009
Primary Completion
Dec 30
2020
Anticipated
Study Completion
Jun 30
2021
Anticipated
Last Update
Oct 02
2018

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

Cross-linking Active Comparator

Corneal collagen cross-linking with riboflavin and UVA light

Cross-linking plus INTACS Active Comparator

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

Criteria 

Inclusion Criteria:

progressive keratoconus or ectasia

Exclusion Criteria:

cornea thinner than 400um
K readings greater than 60D
Central corneal scarring
No Results Posted