Novel Thermoreversible Reverse-Phase-Shift Foam With Deployment System for Treatment of Penetrating Globe Trauma in a Newly Described Porcine Model

• Published in: Military medicine 2024-08, Vol.189 (Supplement_3), p.254-261
• Main Authors: Donaldson, Ross I, Chou, Eva, Tanen, David A, Armstrong, Jonathan K, Buchanan, Oliver J, Graham, Todd L, Cristerna, Nely N, Cambridge, John S, Goldenberg, Diane, Tolles, Juliana, Ross, James D
• Format: Article
• Language: English
• Subjects: Animals; Disease Models, Animal; Eye Injuries, Penetrating - therapy; Intraocular Pressure - physiology; Male; Swine; Warfighter 2023 Supplement
• ISSN: 0026-4075; 1930-613X; 1930-613X
• DOI: 10.1093/milmed/usae088

The initial management of penetrating ocular injuries is a major sight-threatening problem for both civilian and military medicine. A novel device (Eye-Aid) temporarily tamponades leakage from such injuries while being easy to remove upon arrival to specialized ophthalmologic care. Eye-Aid consists of a protective eye shield with an adhesive backing that connects to a portable canister containing rapidly deployable thermoresponsive foam. The aim of this study was to compare the use of the novel Eye-Aid device to control in a new live swine ocular injury model. Bilateral penetrating ocular injuries were created on 14 male Yorkshire swine in a standardized manner using a 16-gauge needle device to puncture the central cornea and cause a full-thickness wound. Researchers randomized eye intervention side, with the contralateral eye used as paired control. Two minutes after the injury, the eye shield components of the Eye-Aid system, which has a sticky pad for attachment to the skin and a luer-lock for foam deployment, were placed bilaterally. Eight minutes after the injury, foam was deployed for the intervention eye according to the device instructions for use. For the control eye, no additional procedures were performed. Six hours post-injury, end A-scan and intraocular pressure (IOP) were measured. Primary study outcome was change in axial length of the globe. Secondary outcomes were as follows: (1) Presence of full anterior chamber collapse, defined as a lack of measurable anterior lens capsule-reflex (ALC-reflex) on A-scan and (2) change in IOP. Outcomes were analyzed as paired intra-animal data, with intervention and control data for each animal. A paired t-test was used to analyze the difference in axial length change and IOP change between treatment groups, whereas a conditional logistic regression was used to analyze dichotomous ALC-reflex outcome and estimate the odds ratio associated with the Eye-Aid device. A significant difference (P