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

History of Changes

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:

Drug Information available for: Riboflavin

U.S. FDA Resources

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 May 21, 2013

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