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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 18, 2014