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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

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ClinicalTrials.gov Identifier: NCT01024322
Recruitment Status : Terminated (Terminated to initiate FDA IND-cleared study protocol)
First Posted : December 2, 2009
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Cxlusa

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Keratoconus Ectasia Degeneration Drug: Ciprofloxicine or Vigamox or other. Drug: Nonsteroidal (Acular, Voltaren Xibrom, etc) Drug: Steroid (FML, Pred Forte, Flarex, etc.)

Study Design
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Study Type : Observational
Actual Enrollment : 1189 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Actual Study Start Date : October 1, 2009
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : February 3, 2017

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   8 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:

  • 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
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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): NCT01024322


Locations
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United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States, 33176
United States, Maryland
TLC Laser Eye Center
Rockville, Maryland, United States, 20852
United States, Virginia
TLC Laser Eye Center
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Cxlusa
Investigators
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Principal Investigator: William Trattler, MD The Center for Excellence in Eye Care
Principal Investigator: Roy Rubinfeld, MD Re: Vision
More Information
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Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01024322    
Other Study ID Numbers: CXL
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: September 2018
Keywords provided by Cxlusa:
Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
Additional relevant MeSH terms:
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Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Diclofenac
Prednisolone acetate
Methylprednisolone 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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists