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

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ClinicalTrials.gov Identifier: NCT01097447
Recruitment Status : Recruiting
First Posted : April 1, 2010
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Cxlusa

March 25, 2010
April 1, 2010
February 3, 2017
December 2009
December 2018   (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 ]
Same as current
Complete list of historical versions of study NCT01097447 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 ]
Same as current
Not Provided
Not Provided
 
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)
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
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Same as current
December 2018
December 2018   (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.
  • 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
Sexes Eligible for Study: All
8 Years and older   (Child, Adult, Older Adult)
No
Contact: Debi Graveman 314 966-3377 dg@cxlusa.com
United States
 
 
NCT01097447
CXL (2)
No
Not Provided
Not Provided
Cxlusa
Cxlusa
Not Provided
Principal Investigator: Parag Majmudar, MD Chicago Cornea Consultants, LTD
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
Principal Investigator: Sherman Reeves, MD Minnesota Eye Consultants, P.A.
Cxlusa
August 2015