Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas

Keratoconus Clinical Trial

Official title:

Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01189864
• Other study ID #: CXL (12 & older)
• Status: Terminated
• Start date: February 1, 2010
• Est. completion date: February 3, 2017

Study information

• Verified date: September 2018
• Source: Cxlusa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3493
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degeneration
• Ectasia
• Keratoconus

Intervention

Drug:
• Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
• Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
• Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	TLC Laser Eye Center	Fairfax	Virginia
United States	Chicago Cornea Consultants, LTD	Hoffman Estates	Illinois
United States	Harvard Eye Associates	Laguna Hills	California
United States	Corneal Consultants of Colorado, P.C	Littleton	Colorado
United States	The Center for Excellence in Eye Care	Miami	Florida
United States	TLC Laser Eye Center	Rockville	Maryland
United States	Ophthalomology Associates	Saint Louis	Missouri
United States	Clear View Eye & Laser Medical Center	San Diego	California
United States	Schwartz Laser Eye Center	Scottsdale	Arizona
United States	Northwest Eye Surgeons	Seattle	Washington
United States	Empire Eye Physicians	Spokane Valley	Washington
United States	Talamo Laser Eye Center	Waltham	Massachusetts
United States	South Shore Eye Care LLP	Wantagh	New York
United States	Davidorf Eye Group	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Cxlusa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within		1 year
Secondary	increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin		1 year