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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cxlusa
• Treatments: Riboflavin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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