Study Stopped
Terminated to initiate FDA IND-cleared study protocol
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
1 other identifier
observational
1,189
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Longer than P75 for all trials
3 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
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 28, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
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 11, 2018
September 1, 2018
7.3 years
October 28, 2009
October 10, 2018
Conditions
Keywords
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)
Ciprofloxicine or Vigamox or other.
Nonsteroidal (Acular, Voltaren Xibrom, etc)
Steroid (FML, Pred Forte, Flarex, etc.)
Interventions
Ciprofloxicine or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc) used up to qid for up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid for 8 weeks.
Eligibility Criteria
Primary care clinic.
You may qualify if:
- 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.
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 (3)
The Center for Excellence in Eye Care
Miami, Florida, 33176, United States
TLC Laser Eye Center
Rockville, Maryland, 20852, United States
TLC Laser Eye Center
Fairfax, Virginia, 22031, 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
Roy Rubinfeld, MD
Re: Vision
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2009
First Posted
December 2, 2009
Study Start
October 1, 2009
Primary Completion
February 3, 2017
Study Completion
February 3, 2017
Last Updated
October 11, 2018
Record last verified: 2018-09