Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

This study is currently recruiting participants.
Verified November 2012 by Cxlusa
Sponsor:
Information provided by (Responsible Party):
Cxlusa
ClinicalTrials.gov Identifier:
NCT01024322
First received: October 28, 2009
Last updated: November 9, 2012
Last verified: November 2012

October 28, 2009
November 9, 2012
October 2009
December 2014   (final data collection date for primary outcome measure)
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01024322 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Primary care clinic.

  • Keratoconus
  • Ectasia
  • Degeneration
  • Drug: Ciprofloxicine or Vigamox or other.
    Ciprofloxicine or Vigamox or other to be used qid till epithelialized.
  • Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)
    Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op
  • Drug: Steroid (FML, Pred Forte, Flarex, etc.)
    Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.
  • Ciprofloxicine or Vigamox or other.
    Intervention: Drug: Ciprofloxicine or Vigamox or other.
  • Nonsteroidal (Acular, Voltaren Xibrom, etc)
    Intervention: Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)
  • Steroid (FML, Pred Forte, Flarex, etc.)
    Intervention: Drug: Steroid (FML, Pred Forte, Flarex, etc.)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
  • Terrien's Marginal Degeneration
  • Ability to provide written informed consent
  • Likely to complete all study visits
  • Minimum corneal thickness of at least 300 250 microns measured by ultrasound or Pentacam for all indications other than Terriens. For Terriens, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

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
Both
8 Years and older
No
Contact: Kristin Williams kristin@lexitaspharma.com
United States
 
NCT01024322
CXL
Not Provided
Cxlusa
Cxlusa
Not Provided
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
Principal Investigator: Roy Rubinfeld, MD Washington Eye Physicians and Surgeons
Cxlusa
November 2012

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