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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

Tracking Information
First Submitted Date  ICMJE March 4, 2010
First Posted Date  ICMJE March 5, 2010
Last Update Posted Date October 2, 2018
Actual Study Start Date  ICMJE January 21, 2009
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
Effectiveness of UV-X cross linking to halt progression of keratoconus [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
Determine whether UV-X treatment is more effective when combined with Intacs or just UV-X alone [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Collagen Cross-Linking for Keratoconus/Ectasia With and Without Intacs
Official Title  ICMJE 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
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Keratoconus
  • Ectasia
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
600
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2010)
400
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • progressive keratoconus or ectasia

Exclusion Criteria:

  • cornea thinner than 400um
  • K readings greater than 60D
  • Central corneal scarring
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01081561
Other Study ID Numbers  ICMJE #20090780
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yaron S. Rabinowitz M.D., Cornea Genetic Eye Institute
Study Sponsor  ICMJE Yaron S. Rabinowitz M.D.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Cornea Genetic Eye Institute
Verification Date December 2017

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