Description:
OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care
OBJECTIVE: The objective of this topic is the development of a non-surgical prototype technology capable of obtaining approval/clearance by the Food and Drug Administration (FDA) that is simple enough for medical personnel to administer in a theater of operations (TO) with minimal additional training that will temporarily stabilize suspected full thickness corneal and corneoscleral injuries during transport to a higher echelon of care where surgical intervention is available. This award will seek offerors to engage the FDA, conduct Good Laboratory Practice (GLP) animal studies, and deliver prototype devices to the government.
DESCRIPTION: Ocular injuries are common occurrences among warfighters, occurring disproportionately compared to injuries affecting more protected areas of the body. The cornea is the first tissue of the ocular structure and often impacted first in trauma. Combat corneal injuries often have a significant impact on vision and there can be significant delays in receiving specialty care for combat ocular trauma. In recent combat operations corneal puncture injuries resulted in poor visual outcomes often resulting in blindness. This is predominantly due to inadequate battlefield interventions to close the open ocular wounds and restore intraocular pressure. A study published in 2020 describes the cause and type of ocular injuries in modern warfare and analyzed all patients with eye injuries from the Iraq and Afghanistan conflicts who were treated at Military Treatment Facilities (MTF). They reported 67,586 persons were admitted to either a United States or United Kingdom MTF for treatment of injuries. 8-10% of wounded soldiers had ocular injuries. 82% of those injuries occurred in battle and 71% were from explosions, and 56% had open globe injuries. [1]
If an open globe (OG) injury is suspected on the battlefield, a rigid eye shield is applied to protect the eye, and the injured warfighter is evacuated to an ophthalmic specialist. Then, OG injuries are closed with sutures to create a watertight seal. This may occur up to 24 hr post-injury currently and is expected to increase up to 72 hr in future combat operations where air evacuation may not be guaranteed. [2-4] However, 53% of OG injured eyes retain intraocular foreign body upon injury and require evacuation to an ophthalmic specialist for surgical intervention. [5]
In order to address corneal and corneoscleral injuries earlier and in a way that is relevant to the
the austerity encountered in a TO, a product that allows for temporary stabilization of corneal and corneoscleral injuries is needed. The temporary cornea repair (TCR) will serve as a bridge management strategy that will remain in place until more definitive care is available. The TCR capability will be in support of MTFs associated with the Military Healthcare System at Role of Care (RoC) 2 (Forward Resuscitative Surgical Team) and RoC 3 (Combat Support Hospital). For a description of RoC please see the reference section.
PHASE I: This topic is intended for technology proven ready to move directly into Phase II. Therefore, the offeror shall provide detail and documentation which demonstrates the accomplishment of a "Phase I-like" effort, including a feasibility study. This includes, insofar as possible, the scientific and technical merit of a non-surgical prototype that will temporarily stabilize suspected full thickness corneal and corneoscleral injuries. Feasibility documentation of particular interest is prior evidence leading to:
• Preliminary data to support the safety and efficacy of the prototype.
• Design specifications for the prototype.
• GLP-biocompatibility (in vitro and in vivo) safety validation data if available.
• Statistically significant performance data if available.
PHASE II: This phase will focus on refinement and optimization of a non-surgical prototype that will temporarily stabilize suspected full thickness corneal and corneoscleral injuries and can be tested in a military relevant environment.
Offerors should propose technology solutions ranging from initial testing of design concepts and evaluation of candidate(s) where study endpoints are defined, and animal models are proposed. ((Technology Readiness level (TRL) 3)) to component validation in a non-GLP laboratory environment to refine hypothesis and identify relevant statistical data required for further technological assessment (TRL 4). Further information regarding DOD Biomedical TRLs can be found in the reference section.
The work may include, but is not necessarily limited to, the following:
• Prototype refinement/maturation progressing towards clinical product
• Preclinical studies (as needed) to support an Investigational Device Exemption (IDE) (or
• other appropriate FDA) submission
• Preclinical studies under GLP (as needed) to support IDE (or other appropriate FDA) submission
• IDE (or other appropriate FDA) submission
• Stability and shelf-life studies if performed
• Establishment of Good Manufacturing Practice (GMP) planning for clinical trials and for market release
• The performer is expected deliver up to 4 prototypes for military relevant testing.
The desired prototype should be simple enough for medical personnel to administer in a TO with minimal additional training, safe enough to use on any suspected corneal or corneoscleral injuries, capable of maintaining a tight seal for an extended period during transport, and effective at stabilizing the eye such that it preserves eyesight.
PHASE III DUAL USE APPLICATIONS: The goal for this Phase is to further development and testing of the prototype through commercialization and FDA approval for its intended use as a temporary stabilization of corneal and corneoscleral injuries. The temporary cornea repair would need to serve as a bridge management strategy that will remain in place until more definitive care is available. Military uses of this technology would support RoC 2 and 3, as well as a mass casualty event where casualties greatly overwhelm first responders and patients need to be triaged to preserve life, limb, and sight.
REFERENCES:
1. [1] Breeze J, Blanch RJ, Mazzoli R, DuBose J, Bowley DM, Powers DB. Comparing the Management of Eye Injuries by Coalition Military Surgeons during the Iraq and Afghanistan Conflicts. Ophthalmology. 2020 Apr;127(4):458-466.
1. [2] Linde, A. S., Mcginnis, L. J. & Thompson, D. M. Multi-battle domain-perspective in military medical simulation trauma training. J Trauma Treat https:// doi. org/ 10. 4172/ 2167- 1222. 10003 91 (2017).
2. [3] Riesberg, J., Powell, D. & Loos, P. The loss of the golden hour. Special Warfare Mag. 30(1), 49–51 (2017).
3. [4] Army, U. S. The US army in multi-domain operations 2028. TRADOC Pamphlet 525, 3–1 (2018).
4. [5] Vlasov, A. et al. Corneal and Corneoscleral Injury in Combat Ocular Trauma from Operations Iraqi Freedom and Enduring Freedom. Mil. Med. 182, 114–119, https://doi.org/10.7205/MILMED-D-16-00041 (2017).
5. Roles of Care doctrine: https://www.jcs.mil/Portals/36/Documents/Doctrine/pubs/jp4_02ch1.pdf
6. Combat Ocular Trauma: Open-globe wounds in operation Iraqi Freedom and Operation Enduring Freedom: risk factors for poor visual outcomes and enucleation; Harris JP, Justin GA, Brooks DI, Woreta FA, Agrawal RV, Ryan DS, Weichel ED, Colyer MH.; Acta Ophthalmol. 2021 Dec.
7. Military Relevant Testing: Development and Characterization of a Benchtop Corneal Puncture Injury Model; Eric J. Snider, Lauren E. Cornell, Jorge M. Acevedo, Brandon Gross, Peter R. Edsall, Brian J. Lund, and David O. Zamora; Sci Rep. 2020; 10: 4218.
KEYWORDS: Cornea injuries, corneoscleral injuries, corneal repair, combat ocular trauma, open globe injuries, roles of care
