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Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

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ClinicalTrials.gov Identifier: NCT01097447
Recruitment Status : Terminated (Terminated to initiate FDA IND-cleared study protocol)
First Posted : April 1, 2010
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Cxlusa

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
Keratoconus Ectasia Degeneration

Study Type : Observational
Actual Enrollment : 2619 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Actual Study Start Date : December 1, 2009
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Group/Cohort
Ciprofloxicine or Vigamox or other
up to qid till epithelialized.
Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom
up to qid for up to 5-10 days postop
Topical steroid (FML, Pred Forte, Flarex
qid for up to 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:   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.
  • Ability to provide written informed consent
  • Likely to complete all study visits
  • Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam

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): NCT01097447


Locations
United States, California
Clear View Eye & Laser Medical Center
San Diego, California, United States, 92121
United States, Colorado
Corneal Consultants of Colorado, P.C
Littleton, Colorado, United States
United States, Illinois
Chicago Cornea Consultants, LTD
Hoffman Estates, Illinois, United States
United States, Minnesota
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota, United States, 55431
United States, Texas
Cornea Associates of Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Cxlusa
Investigators
Principal Investigator: Parag Majmudar, MD Chicago Cornea Consultants, LTD
Principal Investigator: Lance Forstot, MD Corneal Consultants of Colorado, P.C
Principal Investigator: Bradley Bowman, M.D Cornea Associates of Texas
Principal Investigator: Sandy Feldman, M.D Clear View Eye & Laser Medical Center
Principal Investigator: Sherman Reeves, MD Minnesota Eye Consultants, P.A.

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01097447     History of Changes
Other Study ID Numbers: CXL (2)
First Posted: April 1, 2010    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Cxlusa:
Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration

Additional relevant MeSH terms:
Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical