Accession Number:

AD1057038

Title:

Thermoresponsive Reversible Adhesive for Temporary Intervention of Ocular Trauma - II

Descriptive Note:

Technical Report,12 Sep 2016,11 Sep 2017

Corporate Author:

University of Southern California Los Angeles United States

Report Date:

2017-10-01

Pagination or Media Count:

98.0

Abstract:

A pre-clinical research and development project to advance a novel technology for temporary treatment of ocular trauma in austere environments. Open globe injuries, e.g. penetrating injuries to the sclera the white surface of the eye require microsurgical instrumentation, trained ocular surgery specialists to perform the closure and time to perform the procedure. We have developed a reversibly deployable, thermo-responsive hydrogel adhesive that can be placed, in a liquid gel form, through the penetrating injury to fill the laceration in the wall of the eye. As the hydrogel adhesives temperature rises with body temperature, it transitions from a fluid gel into a viscous semi-solid that bridges and seals the penetrating injury for up to thirty days. The entire procedure from injection to fixation can take less than five minutes. Once transported to a ROC4 facility, a specialist can easily remove the adhesive by rehydrating with cold water and aspirating the adhesive away and perform a complete revision. This project pursues four objectives 1 refine and manufacture a 2nd prototype of the hydrogel and accompanying instrument for subsequent GLP validation testing. 2 Perform GLP biocompatibility and in vivo performance testing of these devices to support a subsequent regulatory package. 3 Hold a pre-submission meeting with the FDA to get preliminary feedback on the product designs, proposed indications and clinical safety assessment strategy. 4 Further explore improvements to the adhesive properties of the hydrogel for potential future developments. To date we have made advanced in all four areas in line with our set goals.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE