This project seeks to develop and obtain regulatory approval for an innovative microtechnology- enhanced surgical device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children and adults. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, can result in lifelong deficits in visual perception or blindness. Cataract surgey in adults, with 3 million plus cases per year, is the most common surgical procedure in the United States that, with the aging demographics, will continue to add to our healthcare burden. The first step in pediatric and adult cataract surgery is technically the most challenging and involves the creation of a hole in the thin lens capsule (capsulotomy) to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial intraocular lens. Due to the unique biomechanical properties of the immature lens capsule, current adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. As a result, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non-cataract surgical uses, resulting in suboptimal capsulotomies. In adults, capsulotomy complications manifest as approximately 24,000 cases of capsule tears each year, which mandate alterations in the surgical plan and produce less than ideal vision correction. Recent studies show that perfectly sized and circular capsulotomies produced by femtosecond lasers potentially lead to better clinical and visual outcomes. However femtolasers are extremely expensive for physicians to acquire and cost individual patients an additional $1,500 out of pocket expense, thus limiting the benefits of this technology to a small fraction of the 3 million cataract surgery patients each year. The overall goal of this project is to provide physicians with a low cost device that automatically delivers dimensionally perfect capsuotomies for all pediatric and adult patients undergoing cataract surgery. In Phase I & II, we developed an easy to use disposable capsulotomy device that uses a novel microscale tissue cutting technology to provide quick, consistent capsulotomies across a range of surgical skills. The device is based on a microfabricated cutting ring element housed within a collapsible elastomeric housing to produce precise capsulotomies on a millisecond time scale. Our device is inserted through the standard 2.5 mm corneal incision and re-expands to produce a desired capsulotomy 5-6 mm in diameter. Under Phase IIB, we will perform the FDA mandated certifications and testing required for device regulatory approval. In particular, we seek support for transferring the manufacturing of this innovative microtechnology- enhanced capsulotomy device into a FDA certified production environment and the completion of pre-clinical and clinical studies to meet FDA regulatory requirements.
This Phase IIB application seeks to develop and obtain regulatory approval for a microtechnology- enhanced surgical instrument to aid in lens capsulotomy during cataract surgery and in particular, the treatment of childhood blindness due to lens cataract. Lens cataract is the leading cause of pediatric visual disability, and cataract surgery in adults, with 3 million cases per year, is the most commonly performed surgical procedure in the United States. Cataract removal restores sight and improves the quality of life for both patients and their families. The proposed device uses advanced mictotechnology to simplify and automate a technically challenging surgical task in both pediatric and adult cataract surgery.