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Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

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ClinicalTrials.gov Identifier: NCT01189864
Recruitment Status : Terminated (Terminated to initiate FDA IND-cleared study protocol)
First Posted : August 27, 2010
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Cxlusa

Brief Summary:
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 or disease Intervention/treatment
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
Actual Enrollment : 3493 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Actual Study Start Date : February 1, 2010
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : February 3, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin [ Time Frame: 1 year ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189864


Locations
United States, Arizona
Schwartz Laser Eye Center
Scottsdale, Arizona, United States, 85260
United States, California
Harvard Eye Associates
Laguna Hills, California, United States
Clear View Eye & Laser Medical Center
San Diego, California, United States
San Francisco, California, United States
Davidorf Eye Group
West Hills, California, United States
United States, Colorado
Corneal Consultants of Colorado, P.C
Littleton, Colorado, United States
United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Illinois
Chicago Cornea Consultants, LTD
Hoffman Estates, Illinois, United States, 60169
United States, Maryland
TLC Laser Eye Center
Rockville, Maryland, United States, 20852
United States, Massachusetts
Talamo Laser Eye Center
Waltham, Massachusetts, United States
United States, Missouri
Ophthalomology Associates
Saint Louis, Missouri, United States
United States, New York
South Shore Eye Care LLP
Wantagh, New York, United States, 11793
United States, Ohio
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
United States, Virginia
TLC Laser Eye Center
Fairfax, Virginia, United States, 22031
United States, Washington
Northwest Eye Surgeons
Seattle, Washington, United States
Empire Eye Physicians
Spokane Valley, Washington, United States
Sponsors and Collaborators
Cxlusa
Investigators
Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
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

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01189864     History of Changes
Other Study ID Numbers: CXL (12 & older)
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Diclofenac
Ketorolac Tromethamine
Ketorolac
Bromfenac
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Fluorometholone
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral