Cross-linking of Corneal Collagen (CXL) 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:
NCT01189864
First received: July 20, 2010
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

The purpose of this study is 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. The data generated by this study will not be submitted to the FDA to support commercialization of these riboflavin drops.


Condition Intervention
Keratoconus
Ectasia
Degeneration
Drug: Ciprofloxicin or Vigamox or other.
Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
Drug: Steroid (FML, Pred Forte, Flarex, etc.)

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: 500
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ciprofloxicin or Vigamox or other. Drug: Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc) Drug: Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid 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 to qd for 1-8 weeks.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic.

Criteria

Inclusion Criteria:

  • 12 years of age or older
  • Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
  • 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
  • At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)

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: NCT01189864

Contacts
Contact: Kristin Williams kristin@lexitaspharma.com

Locations
United States, Arizona
Schwartz Laser Eye Center Recruiting
Scottsdale, Arizona, United States, 85260
Principal Investigator: Jay Schwartz, MD         
United States, California
Harvard Eye Associates Recruiting
Laguna Hills, California, United States
Principal Investigator: John Hovanesian, MD         
Clear View Eye & Laser Medical Center Recruiting
San Diego, California, United States
Principal Investigator: Sandy Feldman, MD         
Recruiting
San Francisco, California, United States
Principal Investigator: Daniel Goodman, MD         
Davidorf Eye Group Recruiting
West Hills, California, United States
Principal Investigator: Jonathan Davidorf, MD         
United States, Colorado
Corneal Consultants of Colorado, P.C Recruiting
Littleton, Colorado, United States
Principal Investigator: Lance Forstot         
United States, Florida
The Center for Excellence in Eye Care Recruiting
Miami, Florida, United States
Principal Investigator: Carlos Buznego, MD         
United States, Illinois
Chicago Cornea Consultants, LTD Recruiting
Hoffman Estates, Illinois, United States, 60169
Principal Investigator: Parag Majmudar, MD         
United States, Maryland
TLC Laser Eye Center Recruiting
Rockville, Maryland, United States, 20852
Principal Investigator: Marc Levy, OD         
United States, Massachusetts
Talamo Laser Eye Center Recruiting
Waltham, Massachusetts, United States
Principal Investigator: Jonathan Talamo, MD         
United States, Missouri
Ophthalomology Associates Recruiting
St. Louis, Missouri, United States
Principal Investigator: Gregg Berdy, MD         
United States, New York
South Shore Eye Care LLP Recruiting
Wantagh, New York, United States, 11793
Principal Investigator: Jodi Luchs, MD         
United States, Ohio
Cleveland Eye Clinic Recruiting
Breckville, Ohio, United States, 44141
Principal Investigator: Shamik Bafna, MD         
United States, Virginia
TLC Laser Eye Center Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Marc Levy, OD         
United States, Washington
Northwest Eye Surgeons Recruiting
Seattle, Washington, United States
Principal Investigator: Audrey Rostov, MD         
Empire Eye Physicians Recruiting
Spokane Valley, Washington, United States
Principal Investigator: Mark Kontos, MD         
Sponsors and Collaborators
Cxlusa
Investigators
Principal Investigator: Carlos Buznego, MD The Center for Excellence in Eye Care
Principal Investigator: Marc Levy, OD TLC Laser Eye Center
Principal Investigator: Jodi Luchs, MD South Shore Eye Care LLP
Principal Investigator: Shamik Bafna, MD Cleveland Eye Clinic
Principal Investigator: Parag Majmudar, MD Chicago Cornea Consultants, LTD
Principal Investigator: Jay Schwartz, MD Schwartz Laser Eye Center
Principal Investigator: Jonathan Davidorf, MD Davidorf Eye Group
Principal Investigator: Daniel Goodman, MD Goodman Eye Center
Principal Investigator: Jonathan Talamo, MD Talamo Laser Eye Center
Principal Investigator: Sandy Feldman, MD Clear View Eye & Laser Medical Center
Principal Investigator: Gregg Berdy, MD Ophthalomology Associates
Principal Investigator: Lance Forstot Corneal Consultants of Colorado, P.C
Principal Investigator: Mark Kontos, MD Empire Eye Physicians
Principal Investigator: Audrey Rostov, MD Northwest Eye Surgeons
Principal Investigator: John Hovanesian, MD Harvard Eye Associates
  More Information

No publications provided

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01189864     History of Changes
Other Study ID Numbers: CXL (12 & older)
Study First Received: July 20, 2010
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Corneal Diseases
Keratoconus
Eye Diseases
Diclofenac
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
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
Central Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 16, 2014