Clinical trial NCT01189864: Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
Official title: Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Keratoconus
Ectasia
Degeneration
Lead sponsor: Cxlusa
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 3493
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic.

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.


Eligibility 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

Primary outcomes:
measure: Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within
timeFrame: 1 year
Secondary outcomes:
measure: increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin
timeFrame: 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Schwartz Laser Eye Center
state: Arizona
city: Laguna Hills
country: United States
facility: Harvard Eye Associates
state: California
city: San Diego
country: United States
facility: Clear View Eye & Laser Medical Center
state: California
city: San Francisco
country: United States
state: California
city: West Hills
country: United States
facility: Davidorf Eye Group
state: California
city: Littleton
country: United States
facility: Corneal Consultants of Colorado, P.C
state: Colorado
city: Miami
country: United States
facility: The Center for Excellence in Eye Care
state: Florida
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, LTD
state: Illinois
city: Rockville
country: United States
facility: TLC Laser Eye Center
state: Maryland
city: Waltham
country: United States
facility: Talamo Laser Eye Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Ophthalomology Associates
state: Missouri
city: Wantagh
country: United States
facility: South Shore Eye Care LLP
state: New York
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Fairfax
country: United States
facility: TLC Laser Eye Center
state: Virginia
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
city: Spokane Valley
country: United States
facility: Empire Eye Physicians
state: Washington
Study officials:
affiliation: The Center for Excellence in Eye Care
name: William Trattler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Shore Eye Care LLP
name: Jodi Luchs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Eye Clinic
name: Shamik Bafna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chicago Cornea Consultants, LTD
name: Parag Majmudar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schwartz Laser Eye Center
name: Jay Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Davidorf Eye Group
name: Jonathan Davidorf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Goodman Eye Center
name: Daniel Goodman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Talamo Laser Eye Center
name: Jonathan Talamo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clear View Eye & Laser Medical Center
name: Sandy Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ophthalomology Associates
name: Gregg Berdy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Corneal Consultants of Colorado, P.C
name: Lance Forstot
role: PRINCIPAL_INVESTIGATOR
affiliation: Empire Eye Physicians
name: Mark Kontos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Eye Surgeons
name: Audrey Rostov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Eye Associates
name: John Hovanesian, MD
role: PRINCIPAL_INVESTIGATOR
References: