Laser Activated Collagen Solder for Ophthalmic Surgery

DESCRIPTION (provided by applicant): The significance of this study is the development of a laser tissue welding technique for cornea surgery, provide a foundation for innovative treatment of eye disease and demonstrate the unique properties of laser activated collagen adhesives to repair ophthalmic tissue with high strength and biostability. At least four million ophthalmic procedures are performed annually in the US, many incorporating sutures to close and seal wounds. Yet this method can cause severe complications, can weaken the integrity of the eye and may pose a risk for ocular rupture in case of blunt trauma. Ophthalmic adhesives have been studied as a substitute for sutures but frequently the outcome is less than satisfactory. Laser assisted tissue welding using concentrated collagen derivatives may be an innovative solution to these problems. The goal of Phase I is to demonstrate the feasibility of unique, light activated, collagen solders to seal and close corneal wounds and provide a baseline for survivor subjects in Phase II. Collagen was selected due to its long history as a safe, biocompatible material with the ability to be functionalized into formulations that exhibit remarkable strengths. During Phase I solder compositions will be modified to enhance chemical crosslinks to ocular tissue. Operating parameters will be optimized for a laser that is integrated with a temperature feedback control system to prevent peripheral tissue damage. The adhesive strength of the solder and maximum leak pressure of corneal repairs will be measured. A model will be developed to predict solder biostability in a simulated physiological environment. In vitro studies will be performed using human donor corneas, not suitable for transplantation, to compare CEE's method with suture and cyanoacrylate glue repairs. Endpoints include visual examination, time to complete the procedure, bond integrity and histology.