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
  Purpose

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 Intervention Phase
Keratoconus
Ectasia
Drug: Riboflavin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cornea Genetic Eye Institute:

Primary Outcome Measures:
  • Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Peschke Meditrade

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • progressive keratoconus or ectasia

Exclusion Criteria:

  • cornea thinner than 400um
  • K readings greater than 60D
  • Central corneal scarring
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081561

Locations
United States, California
Eye Surgery Center of Beverly Hills Recruiting
Beverly Hills, California, United States, 90211
Contact: Betty Cardenas    310-423-9640    cardenas.b@cshs.org   
Contact: Martha Bucaram    310 4239640    bucaramm@cshs.org   
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
  More Information

No publications provided

Responsible Party: Yaron S. Rabinowitz M.D., Yaron S Rabinowitz M.D., Cornea Genetic Eye Institute
ClinicalTrials.gov Identifier: NCT01081561     History of Changes
Other Study ID Numbers: #20090780
Study First Received: March 4, 2010
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Pathological Conditions, Anatomical
Corneal Diseases
Eye Diseases
Riboflavin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014