We propose a new interventional device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children. As the leading cause of childhood blindness, lens cataract interferes with the optical performance of the eye and if untreated, results in lifelong deficits in visual perception. The first step in pediatric cataract surgery is technically the most challenging and involves the creation of a hole in the thin and highly elastic lens capsule to provide access for the subsequent removal of the diseased lens and if needed, the implantation of an artificial lens. Due to the unique biomechanical properties of the immature lens capsule, adult procedures for creating the capsulotomy opening, if applied to infants and young children, only have a 20% chance of success. Capsule tears hinder lens removal and affect the mechanical stability and performance of artificial lens implants. Currently, pediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non-cataract surgical uses, resulting in suboptimal pediatric lens capsulotomies. In order to simplify and automate pediatric lens capsulotomies and thus enhance the delivery of vision care to young patients, we propose a micro and nanotechnology-enhanced capsulotomy device to achieve consistent results across a range of surgical skills. The device is based on a proprietary method of tissue cutting in which a microfabricated cutting ring is housed within a collapsible elastomeric housing to produce precise capsulotomies on a microsecond time scale. Our device is inserted through the standard 2.75 mm corneal incision and re-expands to produce a desired capsulotomy of 5.5 mm in diameter. In preliminary work, we have obtained proof of principle for important device functions including capsule cutting and device compressibility. In the proposed studies, we will optimize device component designs, choice of materials, and conduct engineering stress tests. Device function will also be tested using both ex vivo eye models and in a small surgical series in rabbits whose lens capsule mimics the elastic capsule of the pediatric lens. The goal of this Phase I study is the production and functional validation of an automated lens capsulotomy device suitable for extensive device safety and performance trials in Phase II.
This work seeks to develop a microtechnology and nanotechnology-enhanced surgical instrument to aid in the treatment of childhood blindness due to lens cataract. Lens cataract is the leading cause of pediatric visual disabilities, and cataract removal restores sight and improves the quality of life for both patients and their families. The proposed device simplifies and automates a technically challenging surgical task in cataract surgery.
