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

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.

Conditions

• Keratoconus
• Ectasia
• Degeneration

Interventions

DRUG

Ciprofloxicin or Vigamox or other.

Ciprofloxicin or Vigamox or other to be used qid till epithelialized.

DRUG

Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)

Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op

DRUG

Steroid (FML, Pred Forte, Flarex, etc.)

Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.

Sponsors & Collaborators

• Cxlusa

  lead INDUSTRY

Principal Investigators

• William Trattler, MD · The Center for Excellence in Eye Care

• Jodi Luchs, MD · South Shore Eye Care LLP

• Shamik Bafna, MD · Cleveland Eye Clinic

• Parag Majmudar, MD · Chicago Cornea Consultants, LTD

• Jay Schwartz, MD · Schwartz Laser Eye Center

• Jonathan Davidorf, MD · Davidorf Eye Group

• Daniel Goodman, MD · Goodman Eye Center

• Jonathan Talamo, MD · Talamo Laser Eye Center

• Sandy Feldman, MD · Clear View Eye & Laser Medical Center

• Gregg Berdy, MD · Ophthalomology Associates

• Lance Forstot · Corneal Consultants of Colorado, P.C

• Mark Kontos, MD · Empire Eye Physicians

• Audrey Rostov, MD · Northwest Eye Surgeons

• John Hovanesian, MD · Harvard Eye Associates

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-01

Primary Completion

2017-02-03

Completion

2017-02-03

Countries

• United States

Study Locations