Feasibility Study of the Vedera KXS for Treatment of Keratoconus

Inclusion criteria

• 14 years of age or older
• Presence of central or inferior steepening on the Pentacam map
• Axial topography consistent with keratoconus
• I-S ratio > 1.5 on the Pentacam map or topography map
• BSCVA worse than 20/20 (<53 letters on ETDRS chart)
• Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits

Exclusion criteria

• Eyes classified as either normal or atypical normal on the keratoconus severity grading scheme.
• A history of previous corneal surgery or the insertion of Intacs in the eye(s) to be treated.
• Corneal pachymetry <400 microns at diameter to be treated.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
• Clinically significant corneal scarring in the treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the treatment.
• A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
• Diagnosed with autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications likely to affect wound healing.
• Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.