Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia

Completed

Conditions studied: Fruste Keratoconus, Risk of Ectasia

In brief

This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.

Key facts

Study ID

NCT01726283

Run by

Cxlusa

People needed

22

Starts

2011-10-01

Expected to finish

2014-07-01

Last updated by the study team

2015-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Up to 4 potential risk factors for ectasia
• A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
• B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
• C. Age 18 to 25
• D. Planned Residual stromal bed between 250 and 300 microns
• Ability to provide written informed consent
• Likely to complete all study visits
• Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye
• Patients with and without previous laser vision correction are eligible for participation.

You may not qualify if…

• Frank keratoconus, Pellucid, or Post-LASIK ectasia
• Less than 20/30 BSCVA in either eye
• Corneal scarring that markedly affects vision
• Contraindications to any study medications or their components
• Pregnancy or breast feeding
• Active Herpes Corneal Disease

Where it is running

• Schwartz Laser Eye Center — Scottsdale, Arizona, United States
• Clear View Eye & Laser Medical Center — San Diego, California, United States
• The Center for Excellence in Eye Care — Miami, Florida, United States
• TLC Laser Eye Center — Rockville, Maryland, United States
• Talamo Laser Eye Center — Waltham, Massachusetts, United States
• Minnesota Eye Consultants — Minneapolis, Minnesota, United States
• Cleveland Eye Clinic — Breckville, Ohio, United States
• TLC Laser Eye Center — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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