Lateral Flow Assay for the Diagnosis of Open Globe Injuries
Abstract
Ocular trauma resulting in full-thickness penetration of the eyewall (i.e., open-globe injury) is the leading cause of blindness in the injured Warfighter. Although the eye comprises only 0.1% of the frontal profile, eye injuries have been observed in up to 13% of all combat casualties in recent military operations. These open-globe injuries are associated with poor visual outcomes if treatment and stabilization of the injury is delayed. More specifically, the risk of severe infection and blindness decreases with removal of foreign bodies and stabilization of the globe within the first 24 hours. Decisions regarding patient evacuation or preliminary treatment can affect the visual outcome of the injured Soldier. However, these ocular injuries often occur alongside other trauma that might complicate observation of the injured eye required for preliminary diagnosis. This is especially true when observation is performed by a fellow Soldier with minimal opthalmalogic training. As military zones transition farther from established care facilities, rapid preliminary diagnosis of a severe open globe injury while in the field will be required to ensure proper care is received. Therefore, a rapid test capable of accurately determining if the globe is intact is critical to enable the appropriate care by these first responders. The focus of this Vision Research Program proposal is the development of the Ocular Puncture Teardrop Immunoassay Cassette (OPTIC™) device, a robust, deployable assay designed to diagnose full-thickness ocular injuries. A positive result with the OPTIC technology will indicate the presence of fluids typically contained within the eyeball, signaling a penetrating injury and the need for rapid stabilization if visual acuity is to be maintained. To that end, the OPTIC device will be designed so that a teardrop/ocular fluid sample placed on the test strip provides a clear visual result to the medic within minutes, with the simplicity of a common pregnancy test and no instrumentation required. The OPTIC cassette will be developed to enable non-invasive collection of the tear sample to prevent additional discomfort for the wounded Warfighter. Luna Innovations, Inc., has proposed two specific aims for this effort: (1) Selection and validation of an appropriate biomarker that will serve as a in indicator of an open-globe injury. Luna will screen various biomarkers found in internal and external ocular fluids in order to design the test such that detection of the selected biomarker indicates full-thickness injury. Luna will work with Dr. Randolph Glickman, an expert in the characterization of biomarkers associated with ocular trauma, to support this first aim. (2) Implementation of biomarker detection into a deployable format that will support ease of collection and analysis at the point of injury. Luna will work with DCN Diagnosics, leaders in the development and production of lateral flow assays (the format of choice for simple, deployable systems such as OPTIC) to validate the final assay formulation. The successful development of this simple, rapid, handheld test will enable point-of-care diagnosis of an open globe injury with minimal training, which will thereby support informed decisions regarding evacuation priorities or preliminary treatments to stabilize severe ocular injuries.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2211096
Entities
People
- Lauren Costella
Organizations
- Luna Innovations
- United States Army