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

This study is currently recruiting participants.
Verified December 2012 by Cornea Genetic Eye Institute
Sponsor:
Information provided by (Responsible Party):
Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute
ClinicalTrials.gov Identifier:
NCT01081561
First received: March 4, 2010
Last updated: December 17, 2012
Last verified: December 2012

March 4, 2010
December 17, 2012
June 2009
June 2014   (final data collection date for primary outcome measure)
Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081561 on ClinicalTrials.gov Archive Site
Determine whether UV-X treatment is more effective when combined with Intacs or just UV-X alone [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Keratoconus
  • Ectasia
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 Name: Peschke Meditrade
  • Active Comparator: Cross-linking
    Corneal collagen cross-linking with riboflavin and UVA light
    Intervention: Drug: Riboflavin
  • Active Comparator: Cross-linking plus INTACS
    Corneal collagen cross-linking with riboflavin and UVA light plus INTACS
    Intervention: Drug: Riboflavin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • progressive keratoconus or ectasia

Exclusion Criteria:

  • cornea thinner than 400um
  • K readings greater than 60D
  • Central corneal scarring
Both
21 Years to 65 Years
No
Not Provided
United States
 
NCT01081561
#20090780
Yes
Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute
Yaron S. Rabinowitz M.D.
Not Provided
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
Cornea Genetic Eye Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP