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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
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 Intervention Phase
Keratoconus
Ectasia
Degeneration
 Drug: Ciprofloxicine or Vigamox or other.
Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)
Drug: Steroid (FML, Pred Forte, Flarex, etc.)
 Phase 4

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: 1500
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ciprofloxicine or Vigamox or other. Drug: Ciprofloxicine or Vigamox or other.
Ciprofloxicine or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc) Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.) Drug: Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 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.
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024322

Contacts
Contact: Kristin Williams kristin@lexitaspharma.com

Locations
United States, Florida
The Center for Excellence in Eye Care Recruiting
Miami, Florida, United States
United States, Maryland
Washington Eye Physicians and Surgeons Recruiting
Chevy Chase, Maryland, United States
Sponsors and Collaborators
Cxlusa
Investigators
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
Principal Investigator: Roy Rubinfeld, MD Washington Eye Physicians and Surgeons
  More Information

No publications provided

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01024322     History of Changes
Other Study ID Numbers: CXL
Study First Received: October 28, 2009
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
Diclofenac
Bromfenac
Ketorolac Tromethamine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
 Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013