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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01081561
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2010
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Keratoconus Ectasia Drug: Riboflavin Phase 2 Phase 3

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : January 21, 2009
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 10 years ]
    Any change of 1 or more of the following indices will be classified as progression. The following parameters will be studied Max K, Steep K, I-S value,Min OCT(pachymetry



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081561


Locations
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United States, California
Cornea Eye Institute, 50 North La Cienaga Blvd, #340
Beverly Hills, California, United States, 90211
Sponsors and Collaborators
Yaron S. Rabinowitz M.D.
Investigators
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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
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Responsible Party: Yaron S. Rabinowitz M.D., Yaron S Rabinowitz M.D., Cornea Genetic Eye Institute
ClinicalTrials.gov Identifier: NCT01081561    
Other Study ID Numbers: #20090780
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents