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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

This study is currently recruiting participants.
Verified November 2012 by Cxlusa
Sponsor:
Information provided by (Responsible Party):
Cxlusa
ClinicalTrials.gov Identifier:
NCT01097447
First received: March 25, 2010
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication


Condition
Keratoconus
Ectasia
Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cxlusa:

Primary Outcome Measures:
  • Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ciprofloxicine or Vigamox or other
up to qid till epithelialized.
Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom
up to qid for up to 5-10 days postop
Topical steroid (FML, Pred Forte, Flarex
qid for up to 8 weeks

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • 8 years of age or older
  • Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration.
  • Diagnosis of FFKC
  • History of Radial Keratotomy with fluctuating vision.
  • Ability to provide written informed consent
  • Likely to complete all study visits
  • Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

Exclusion Criteria:

  • Severe corneal scarring that markedly affects vision
  • Contraindications to any study medications or their components
  • Pregnancy or breast feeding
  • Active Herpes Corneal Disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097447

Contacts
Contact: Kristin Williams kristin@lexitaspharma.com

Locations
United States, California
LA Sight Recruiting
Los Angeles, California, United States
Clear View Eye & Laser Medical Center Recruiting
San Diego, California, United States, 92121
United States, Colorado
Corneal Consultants of Colorado, P.C Recruiting
Littleton, Colorado, United States
United States, Illinois
Chicago Cornea Consultants, LTD Recruiting
Hoffman Estates, Illinois, United States
Contact: Jenna Piel     951-653-5566        
United States, Texas
Cornea Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Cxlusa
Investigators
Principal Investigator: Parag Majmudar, MD Chicago Cornea Consultants, LTD
Principal Investigator: David Wallace, MD LA Sight
Principal Investigator: Lance Forstot, MD Corneal Consultants of Colorado, P.C
Principal Investigator: Bradley Bowman, M.D Cornea Associates of Texas
Principal Investigator: Sandy Feldman, M.D Clear View Eye & Laser Medical Center
  More Information

No publications provided

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01097447     History of Changes
Other Study ID Numbers: CXL (2)
Study First Received: March 25, 2010
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cxlusa:
Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration

Additional relevant MeSH terms:
Dilatation, Pathologic
Keratoconus
Pathological Conditions, Anatomical
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013