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

This study is currently recruiting participants.
Verified August 2015 by Cxlusa
Sponsor:
ClinicalTrials.gov Identifier:
NCT01097447
First Posted: April 1, 2010
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cxlusa
  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
Keratoconus Ectasia Degeneration

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 ]

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 ]

Estimated Enrollment: 500
Study Start Date: December 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Debi Graveman 314 966-3377 dg@cxlusa.com

Locations
United States, California
Clear View Eye & Laser Medical Center Recruiting
San Diego, California, United States, 92121
United States, Colorado
Corneal Consultants of Colorado, P.C Recruiting
Littleton, Colorado, United States
United States, Illinois
Chicago Cornea Consultants, LTD Recruiting
Hoffman Estates, Illinois, United States
United States, Minnesota
Minnesota Eye Consultants, P.A. Recruiting
Bloomington, Minnesota, United States, 55431
United States, Texas
Cornea Associates of Texas Recruiting
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.
  More Information

Responsible Party: Cxlusa
ClinicalTrials.gov Identifier: NCT01097447     History of Changes
Other Study ID Numbers: CXL (2)
First Submitted: March 25, 2010
First Posted: April 1, 2010
Last Update Posted: February 3, 2017
Last Verified: August 2015

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