Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
Information source: Cxlusa
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratoconus; Ectasia; Degeneration
Intervention: Ciprofloxicin or Vigamox or other. (Drug); Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc) (Drug); Steroid (FML, Pred Forte, Flarex, etc.) (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Cxlusa Official(s) and/or principal investigator(s):
Carlos Buznego, MD, Principal Investigator, Affiliation: The Center for Excellence in Eye Care
Marwa Adi, MD, Principal Investigator, Affiliation: Washington Eye Physicians and Surgeons
Jodi Luchs, MD, Principal Investigator, Affiliation: South Shore Eye Care LLP
Shamik Bafna, MD, Principal Investigator, Affiliation: Cleveland Eye Clinic
Parag Majmudar, MD, Principal Investigator, Affiliation: Chicago Cornea Consultants, LTD
Jay Schwartz, MD, Principal Investigator, Affiliation: Schwartz Laser Eye Center
Jonathan Davidorf, MD, Principal Investigator, Affiliation: Davidorf Eye Group
Daniel Goodman, MD, Principal Investigator, Affiliation: Goodman Eye Center
Jonathan Talamo, MD, Principal Investigator, Affiliation: Talamo Laser Eye Center
Sandy Feldman, MD, Principal Investigator, Affiliation: Clear View Eye & Laser Medical Center
Gregg Berdy, MD, Principal Investigator, Affiliation: Ophthalomology Associates
Lance Forstot, Principal Investigator, Affiliation: Corneal Consultants of Colorado, P.C
Mark Kontos, MD, Principal Investigator, Affiliation: Empire Eye Physicians
Audrey Rostov, MD, Principal Investigator, Affiliation: Northwest Eye Surgeons
John Hovanesian, MD, Principal Investigator, Affiliation: Harvard Eye Associates
Overall contact:
Kristin Williams, Email: kristin@lexitaspharma.com
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.
Clinical Details
Official title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
Secondary outcome: increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kristin Williams, Email: kristin@lexitaspharma.com
Schwartz Laser Eye Center, Scottsdale, Arizona 85260, United States; Recruiting
Jay Schwartz, MD, Principal Investigator
Harvard Eye Associates, Laguna Hills, California, United States; Recruiting
John Hovanesian, MD, Principal Investigator
Clear View Eye & Laser Medical Center, San Diego, California, United States; Recruiting
Sandy Feldman, MD, Principal Investigator
San Francisco, California, United States; Recruiting
Daniel Goodman, MD, Principal Investigator
Davidorf Eye Group, West Hills, California, United States; Recruiting
Jonathan Davidorf, MD, Principal Investigator
Corneal Consultants of Colorado, P.C, Littleton, Colorado, United States; Recruiting
Lance Forstot, Principal Investigator
The Center for Excellence in Eye Care, Miami, Florida, United States; Recruiting
Carlos Buznego, MD, Principal Investigator
Chicago Cornea Consultants, LTD, Hoffman Estates, Illinois 60169, United States; Recruiting
Parag Majmudar, MD, Principal Investigator
Washington Eye Physicians and Surgeons, Chevy Chase, Maryland, United States; Recruiting
Marwa Adi, MD, Principal Investigator
Talamo Laser Eye Center, Waltham, Massachusetts, United States; Recruiting
Jonathan Talamo, MD, Principal Investigator
Ophthalomology Associates, St. Louis, Missouri, United States; Recruiting
Gregg Berdy, MD, Principal Investigator
South Shore Eye Care LLP, Wantagh, New York 11793, United States; Recruiting
Jodi Luchs, MD, Principal Investigator
Cleveland Eye Clinic, Breckville, Ohio 44141, United States; Recruiting
Shamik Bafna, MD, Principal Investigator
Northwest Eye Surgeons, Seattle, Washington, United States; Recruiting
Audrey Rostov, MD, Principal Investigator
Empire Eye Physicians, Spokane Valley, Washington, United States; Recruiting
Mark Kontos, MD, Principal Investigator
Additional Information
Starting date: June 2010
Last updated: November 9, 2012
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