Collagen Crosslinking 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: NCT01024322
• Other study ID #: CXL
• Status: Terminated
• Start date: October 1, 2009
• 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1189
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• 8 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.

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

Locations

Country	Name	City	State
United States	TLC Laser Eye Center	Fairfax	Virginia
United States	The Center for Excellence in Eye Care	Miami	Florida
United States	TLC Laser Eye Center	Rockville	Maryland

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