Dr. Aaron Waite is an author on a recently published scientific article, titled “Pilot Safety Study of a Microfabricated Device for Anterior Stromal Puncture to Treat Corneal Epithelial Disease in the Optical Axis.” Dr. Waite, founder and lead surgeon at Waite Vision, worked on this study with Drs. Edward Chaum, Brian Kim, Steven Kane, Forrest B. Swann, Lloyd R. Wade, Christopher D. Riemann, and Michael E. Snyder. The goal of their study was to test the safety of a device known as a “plexitome,” commonly used to treat eye conditions such as recurrent corneal erosions (RCE).
The plexitome is an FDA-registered Class 1 medical device designed to treat (RCE) and other corneal conditions like eye trauma or epithelial basement membrane dystrophies (EBMDs) without causing visible scars. The device uses micropuncture to create tiny, shallow imprints in the corneal stroma, which help the corneal surface heal. The study, involving 45 patients, showed that the plexitome was safe to use without any adverse effects. The results suggest that this device may be a safe and effective alternative for treating corneal epithelial diseases, especially in the optical axis of the eye.
In the study, researchers used the plexitome to create tiny punctures in the cornea, similar to anterior stromal puncture; however, instead of using a small bent needle for micropuncture the safer plexitome device is used which avoids corneal scarring. Patients with corneal epithelial diseases were treated either through the corneal epithelium or after removing loose epithelial tissue. The procedure involved anesthetizing the eye, debriding the area if needed, and then pressing the device gently onto the corneal surface to create the punctures. The treated areas were then monitored for 30 days to assess healing and any adverse effects.
The treatment using the plexitome device involves creating small, micropunctures in the cornea under local anesthesia in a diameter of 5mm. The device is simply gently pressed against the cornea and released. This can be repeated multiple times to cover the surface area of the affected area of the cornea. These punctures help the corneal epithelial surface adhere better and heal more effectively. The treatment is followed by standard post-procedure care, including lubrication drops, antibiotic drops, and bandage contact lenses if needed, depending on the individual doctor’s preferred method and patient need.
The study involved 45 adult patients with various corneal epithelial diseases, including recurrent corneal erosions (RCEs), epithelial basement membrane dystrophy (EBMD), and other conditions causing epithelial loss. The majority of patients had RCE. There were a selection of both male and female patients, and an age range of 21-83 years. The patients were treated using the plexitome, though their treatment before or after the plexitome varied per physician. The study found that the treatment was safe, with no significant adverse events or visible scarring observed. By day 7 after imprinting with the plexitome, only two patients had signs of the micropuncture treatment when viewed with the slit-lamp. There were no instances of corneal scarring, stromal haze, or infections. Overall, the treatment was well-tolerated, with no significant complications observed.
Dr. Waite and his fellow researchers worked to determine the safety of using the new plexitome device, and the results suggest that this technique offers a safe and effective alternative to traditional treatments, especially in the optical axis, where avoiding visible scarring is crucial. Further long-term studies are needed to confirm these findings and assess the device’s impact on corneal anatomy and refractive status.
