Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Cxlusa
Sponsor:
Information provided by (Responsible Party):
Cxlusa
ClinicalTrials.gov Identifier:
NCT01024322
First received: October 28, 2009
Last updated: May 7, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
TLC Laser Eye Center Recruiting
Rockville, Maryland, United States, 20852
United States, Virginia
TLC Laser Eye Center Recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Cxlusa
Investigators
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
Principal Investigator: Roy Rubinfeld, MD Re: Vision
  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: May 7, 2014
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:
Keratoconus
Corneal Diseases
Eye Diseases
Diclofenac
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2014