Micro-technology Enhanced Pediatric Lens Capsulotomy Device

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DESCRIPTION (provided by applicant): We propose an innovative microtechnology-enhanced surgical 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 disposable microtechnology-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 sub-millisecond time scale. Our device is inserted through the standard 2.8 mm corneal incision and re-expands to produce a desired capsulotomy of 5 mm in diameter. In Phase I, we sucessfully demonstrated project feasibility by developing device protoypes that met specifications in terms of dimensions for intraocular use, compressibility, and capsule cutting. In the proposed Phase II studies, we will develop a commercial version of the capsulotomy device, conduct engineering bench testing, and undertake surgical validation in an accepted rabbit model, with the goal of achieving product design freeze. In parallel, as a second aim, we will also develop a compact table-top console to provide power, timing circuits, vacuum, diagnostics, and safety alerts for the casulotomy device. Results from this Phase II work will allow us to advance to device certification by good laboratory practice (GLP) accredited facilities as required for clinical trial initiation and ultimte FDA approval.