Description:
OBJECTIVE: Develop a stereo-photo Smartphone ophthalmic slitlamp (system), with accessories and software applications for ocular diagnosis in remote or austere locations where ophthalmic or optometric support is unavailable, such as military forward operating bases, ships afloat, or disaster areas, or humanitarian missions. DESCRIPTION: Ocular injuries currently account for approximately 13-22% of all combat casualties and up to 32% in disaster scenarios (1,2), while untold others experience other less devastating eye issues while deployed. Because the diagnosis and treatment of ocular trauma and disease are daunting to most non-ophthalmic providers, most opt to refer ocular patients to theater ophthalmologists or optometrists for evaluation of all but the most routine conditions; most often, however, those assets are very limited or non-existent in military operations so that transferring even relatively simple ocular conditions entails significant risk, or may not be possible at all (eg, ships afloat or humanitarian missions). In this regard, telediagnosis should offer both rapidity of evaluation and increased security; evacuation of the patient can then be more judiciously advisedor avoidedbased on evaluation of the tele-information. Because Ophthalmology is so heavily reliant on visual information, high-quality photographic attachments are very helpful to the teleconsultants (3). Limitations to current photodocumentation are the 2-dimensional nature of standard photographs, the inability to selectively focus standard cameras on the microscopic structures of the ocular anatomy on which diagnoses can hinge, and overall resolution. Because of their size, weight, cost, fragility, and training requirements, conventional and portable slitlamps are not typically deployed in all forward clinical settings such as ships"sick bays, Forward Operating Bases (FOBs), Battalion Aid Stations (BAS), disaster areas, or humanitarian missions, and when available are not equipped with photo capability (a technique that requires considerable skill in itself). Smartphone technology has recently put high quality photography, advanced processing capability, and robust connectivity into the hands of technically untrained populations. Still photos or video can be captured and quickly edited for rapid dispatch via the internet in near real-time, or can be stored for later transmission. Continual advances in smartphone hardware have increased photographic resolution while decreasing the size of the cameras, and have even broached into 3-D applications. Such handheld capability is of significant interest to military Ophthalmology. Inherent portability, connectivity, and affordability would allow use by minimally trained personnel and deployment to areas heretofore considered inaccessible or impractical. However, mere adaptation of existing smartphones may not answer all of the specialty"s needs. For example, a key aspect would be the capability to do high-resolution stereo photography of ocular structures that vary in scale from a few centimeters (external macro photography), to millimeters (microphotography of the surface of the eye), to sub-millimeter or microns (eg, internal structures such as the anterior chamber, lens and fundus). Additionally, selective illumination by slit beams of light cast at oblique angles allows greater precision in diagnosis unavailable in current smartphone technology. Software applications should facilitate ophthalmic telediagnosis, to include collection of patient ocular exam data as well as enhanced photography/ videography and bundling for teleconsultation. Capacity should include both real-time and store-and-forward teleconsultation. PHASE I: Develop an initial concept design, and create working models of key elements of a smartphone slitlamp or slitlamp system. Phase 1 deliverables should include: a highly specific design strategy that addresses and incorporates each of the listed minimum functional requirements, particularly with regard to ease of use, and modularity and adaptability for use in different configurations; proof of concept model(s) that addresses minimum functional requirements, particularly with regard to photographic and illumination requirements; and, initial examination, documentation, and teleconsultation software applications. Minimum functional requirements include, but should not be limited to: ability to capture high quality 2-dimensional and stereo-photography (and/ or videography) of the eye(s) and adnexa; ability to transmit bundled examination data and photo information as near-real-time, or store-and-forward; ability to focus at different physical scales, from macro- (e.g., single eye or both; eyelids; adnexa; and gross ocular structures), to micro- (e.g., cornea, iris, lens, fundus etc) and sub-millimeter-scales, potentially including micron-scale (e.g., corneal epithelium , anterior chamber cells, etc); ability to focus principally on external and anterior internal ocular structures (i.e., lids, conjunctiva, sclera, cornea, etc) with flexibility to image deeper internal ocular structures (e.g., lens, fundus, optic nerve); ability to select lighting and illumination patterns from various direct or oblique angles, including, but not limited to, broad or diffuse beams, slit-beams, and pencil beams of light; ability to select from various illumination colors and wavelengths, such as (but not limited to) white, cobalt blue, red-free, and infrared lights; modular adaptability for use in a variety of platforms and configurations, such as freehand-operated, to stabilized-handheld (eg, a portable slit lamp platform), to table mounted (eg, a conventional slit lamp platform); adaptability to use in a variety of settings and environments, such as first-responder/ casualty-side in a field setting; bedside; or fixed facility/ clinic/ sick bay; adaptability to use in a variety of climatic conditions, such as extremes of heat and humidity, dust, rain, altitude, barometric pressure, etc; robust physical ruggedness to survive physical activities and abuses common to and expected of a combat, disaster, or otherwise austere environment; consideration of protection of camera lenses from scratching or other degradations that could adversely affect photo quality (especially at micro- and micron-scales); software applications to facilitate a detailed ocular examination (including pupil examination) by providers who are untrained or minimally trained in ocular diagnosis; overall ease of use by minimally trained personnel; appropriate instructional material and software. Due to the time constraints regarding IRB and DoD second level review, no human or animal use studies should be proposed or executed during the six-month Phase I period. PHASE II: Construct and demonstrate the operation of a prototype of the above integrated smartphone slitlamp system, to include both hardware and software components. Demonstrate the ability of the system to perform in a variety of situations and environments such as in the field, at the bedside, or in a more stable and fixed mode. Demonstrate easy use with acceptable results (photos and examinations) by minimally trained personnel. Demonstrate physical ruggedness. PHASE III: The vision of this research is to create a novel ocular telediagnostic tool that can be used by minimally trained providers in remote, austere, or isolated environments such as military forward operating bases, ships afloat and away from port, or on humanitarian missions and in disaster zones where medical infrastructure and capability is reduced or nascent. Development of a smartphone-based ophthalmic slit lamp (or slitlamp system) would allow high-quality telemedicine consultations with ophthalmologists and optometrists, thereby potentially providing on-site diagnosis and treatment capability, and probably avoiding evacuation and minimizing security risks. The focus should be on technology transition or commercialization of this product. FDA approval (if needed) should be initiated or completed during this phase. Beyond military interest, commercial interest in this product could include disaster readiness organizations as well as humanitarian-relief organizations, and would not be limited to ocular diagnostics. Teleconsultation software applications could be attractive to other medical specialties. Advanced and stereophotographic capabilities could be attractive to the general public. REFERENCES: 1. Centers for Disease Control and Prevention. Surveillance for World Trade Center disaster health effects among survivors of collapsed and damaged buildings. In: Surveillance Summaries, April 7 2006. MMWR 2006; 55 (No. SS-2). 2. Mines M, Thach A, Mallonee S, Hildebrand L, Shariat S. Ocular injuries sustained by survivors of the Oklahoma City bombing. Ophthalmology 2000; 107: 837-843. 3. Mines MJ, Bower KS, Lappan CM, Mazzoli RA, Poropatich RK. The United States Army Ocular Teleconsultation program 2004 through 2009. Am J Ophthalmol 2011; 152: 126-132. 4. Poropatich RK, DeTreville R, Lappan C, Barrigan CR. The US Army Telemedicine program: general overview and current status in Southwest Asia. Telemed and e-Health 2006; 12: 396-408. 5. McManus J, Salinas J, Morton M, Lappan C, Poropatich R. Teleconsultation program for deployed soldiers and healthcare professionals in remote or austere environments. Prehospital Disast Med 2008; 23: 210-216. 6. Ehlers JP, Shah CP. The Wills Eye Manual. Philadelphia, Wolters Kluwers: 2008. 7. Carlson NB, Kurtz D. Clinical Procedures for Ocular Examination. New York, McGraw Hill: 2004.
