Pilot Safety Study of a Microfabricated Device for Anterior Stromal Puncture to Treat Corneal Epithelial Disease in the Optical Axis.

ABSTRACT

PURPOSE: Anterior stromal puncture is an inexpensive and widely used technique at the slit lamp to treat recurrent corneal erosions (RCE), common sequelae of corneal abrasions, trauma, and epithelial basement membrane dystrophies (EBMDs). The purpose of this study was to determine safety of a novel anterior stromal micropuncture device (termed a "plexitome") for use in the optical axis of the cornea. METHODS: We performed an IRB-approved clinical pilot study on 45 patients with diverse corneal pathologies to determine the safety of the plexitome device and examined corneal healing responses clinically for a minimum of 30 days after treatment. Follow on efficacy data was collected for treated patients with RCE. Micropuncture treatment was performed either through loose epithelial tissue or after debridement using a cotton tip at the slit lamp. After "imprinting," patients were treated with topical medications including antibiotics, hypertonic saline/ointment, bandage contact lenses, and/or patching according to the treating physician's routine care for the condition. RESULTS: Micropuncture using the "plexitome" device did not create visible scars in the corneal stroma of the 45 patients treated and followed for at least 30 days. Photographic evidence of imprinting was seen at in 1 patient at 30 days. There were no significant adverse events associated with treatment. CONCLUSIONS: Micropuncture of the cornea using the "plexitome" device does not create optically evident anterior stromal scarring after treatment. Micropuncture using the device may be an effective way of treating RCE and other corneal manifestations of EBMD in the optical axis, which is not currently possible using standard anterior stromal puncture methods.