Study Stopped
Terminated to initiate FDA IND-cleared study protocol
Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
1 other identifier
observational
3,493
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 20, 2010
CompletedFirst Posted
Study publicly available on registry
August 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2017
CompletedOctober 12, 2018
September 1, 2018
7 years
July 20, 2010
October 10, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
1 year
Secondary Outcomes (1)
increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
1 year
Study Arms (3)
Ciprofloxicin or Vigamox or other.
Nonsteroidal (Acular, Voltaren Xibrom, etc)
Steroid (FML, Pred Forte, Flarex, etc.)
Interventions
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.
Eligibility Criteria
Primary care clinic.
You may qualify if:
- 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)
You may not qualify if:
- Severe corneal scarring that markedly affects vision
- Contraindications to any study medications or their components
- Pregnancy or breast feeding
- Active Herpes Corneal Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cxlusalead
Study Sites (16)
Schwartz Laser Eye Center
Scottsdale, Arizona, 85260, United States
Harvard Eye Associates
Laguna Hills, California, United States
Clear View Eye & Laser Medical Center
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Davidorf Eye Group
West Hills, California, United States
Corneal Consultants of Colorado, P.C
Littleton, Colorado, United States
The Center for Excellence in Eye Care
Miami, Florida, 33176, United States
Chicago Cornea Consultants, LTD
Hoffman Estates, Illinois, 60169, United States
TLC Laser Eye Center
Rockville, Maryland, 20852, United States
Talamo Laser Eye Center
Waltham, Massachusetts, United States
Ophthalomology Associates
St Louis, Missouri, United States
South Shore Eye Care LLP
Wantagh, New York, 11793, United States
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
TLC Laser Eye Center
Fairfax, Virginia, 22031, United States
Northwest Eye Surgeons
Seattle, Washington, United States
Empire Eye Physicians
Spokane Valley, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2010
First Posted
August 27, 2010
Study Start
February 1, 2010
Primary Completion
February 3, 2017
Study Completion
February 3, 2017
Last Updated
October 12, 2018
Record last verified: 2018-09