Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

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Infants and young children are unable to communicate about loss or disturbance of vision, making it difficult to diagnose vision-threatening diseases before irrevocable vision loss occurs. Commercially available pediatric retinal imaging technologies, including handheld OCT (HH-OCT) and handheld fundus cameras, can be used to screen for and diagnose eye disease in these young patients; however, these technologies have significant drawbacks, such as poor usability, high cost and/or causing significant patient discomfort and stress. One important application of pediatric retinal imaging is the screening of preterm infants for retinopathy of prematurity (ROP). The development of HHOCT has significantly improved our understanding of the progression of ROP, but its use as a diagnostic tool for ROP has been limited by the high cost and poor usability of commercial systems. Similarly, currently available widefield color fundus cameras are prohibitively expensive, and can be stress inducing due to the use of a contact lens and bright illumination flash. Stress associated with the use of these devices can complicate repeat imaging, as young children quickly develop and aversion response to the device. In addition, repeated exposures to stress has been shown to affect neural development in preterm infants. Thus, capturing images in infants and young children with either of these types of systems is expensive, challenging, requiring specialized research staff with significant training. Clearly, there exists a need for a lower- cost and easier to use pediatric retinal imaging system, ideally one that does not cause stress in pre-term infants. This Exploratory/Developmental Research Grant proposal brings together a team of engineers and clinician- scientists with expertise in ophthalmic imaging technology development and translation to develop a pediatric- specific hand-held scanning laser ophthalmoscope (SLO) to address the shortcomings of current commercially available pediatric retinal imaging devices. This technology will substantially improve the standard of care for infants and young children who are currently underserved by existing technologies. To address this unmet clinical need, we propose to construct a prototype, pediatric-specific SLO device and evaluate its clinical feasibility through the following Specific Aims. Specific Aim 1: Develop a Dual-mode, Widefield SLO System with an Ergonomic Handheld Probe. This device will operate in two modes; a non-contact mode providing a 60° FOV and 18 µm resolution at up to 10 frames per second, and a contact mode employing commercially available single-use contact lenses, providing a 120° FOV and 44 µm resolution, also at up to 10 fps. We will also develop real-time image acquisition and display software. Specific Aim 2: Pilot Clinical Study. Use of the proposed SLO system will be compared to current commercial alternatives, comparing the non-contact mode with a non- contact fundus cameras, and the contact mode with a widefield SLO and a contact, widefield fundus camera. The expected outcome of this proposal is the development and initial validation of a pediatric-specific SLO system that will form the basis of future efforts towards clinical validation and ultimate commercialization.