Research Project
9332210
PROJECT SUMMARY / ABSTRACT This project seeks to obtain regulatory approval and to conduct pre-commercialization manufacturing R&D activities 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 surgery in adults, with 4 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 ~50,000 cases of capsule tears each year, which alter the surgical plan and can produce suboptimal vision correction. Recent studies show that perfectly sized and circular capsulotomies produced by femtosecond lasers potentially lead to better clinical outcomes. However femtolasers are extremely expensive for physicians to acquire and cost patients an extra ~$1,500 out of pocket per eye, thus limiting the benefits of this technology to a small fraction of the ~4 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, & IIB, 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 nitinol capsulotomy ring element housed within a collapsible elastomeric housing to produce precise capsulotomies on a millisecond time scale using a multipulse electrical energy algorithm. The device is inserted through a small corneal incision and re-expands to produce a 5-5.5 mm diameter capsulotomy. Under the CRP program, we will perform a FDA-mandated clincial trial needed for device approval. In addition, we will conduct late stage R&D in collaboration with manufacturing partners to develop new technology for efficient high-volume manufacturing. The successful completion of these activities will position this product for successful market entry and thereby provide low cost, innovative vision care to all.
