We propose the development and commercialization of a handheld, TeleOphthalmoscope"""""""" that is capable of performing visual assessment of the human retina. The device is intended as a screening or diagnostic tool for diabetic retinopathy and other abnormalities of the retina. This proposal leverages the latest developments in optics, digital imagers, and image processing techniques to produce a novel, inexpensive device suitable for screening patients via telemedicine in a variety of care settings. Because of its low cost, small size, simplicity, fully automated fast image capture, and minimal training requirement, it will enable nurses, paramedics, ER staff, primary care physicians, health care technicians, and other non-eye-specialists to perform examinations that historically have been the province of eye specialists. Settings include hospitals, nursing homes, life care facilities, prisons, schools, ambulances, military environments, clinics, and homes. The device will incorporate capabilities for the transmission of images over the internet to an expert processing center for archival storage, and for interpretation and diagnosis by retinal specialists. This device has the potential to make retinal screening more affordable and accessible to the public, especially in underserved or rural areas. The device also makes it possible to diagnose retinal trauma """"""""pre- hospital"""""""" (e.g., at the site of an injury or in an ambulance), and have the appropriate specialist ready at the treatment site to provide immediate care. Use in military, academic, and prison settings is also possible. Our goal is """"""""bringing the screening to the patient"""""""", rather than """"""""bringing the patient to the screening,"""""""" and to make screening easier for both patients and practitioners.
Specific aims of this Phase 1 proposal refining the design previously developed, constructing and bench testing an ergonomic prototype, and conducting a masked, pilot human study at the New England Eye Institute with 20 patients to determine whether the camera has sufficient image quality to screen patients for diabetic retinopathy. Results will be compared to those obtained with a high-quality tabletop retinal camera.
The proposed project is for the Phase 1 development of a handheld digital retinal camera. The camera is to be used as a screening or diagnostic tool for diabetic retinopathy, hypertensive retinopathy, CMV retinitis, glaucoma, detached retina, and other abnormalities of the retina. Through the use of novel, fully automated fast image capture, the device will enable non-eye specialists such as primary care physicians and nurse practitioners at remote sites to acquire and transmit retinal images to a remote processing site for interpretation and diagnosis by retinal specialists. Our goal is """"""""bringing the screening to the patient"""""""", rather than """"""""bringing the patient to the screening."""""""" This Phase 1 proposal will focus on creating a fully functional, ergonomic, handheld prototype of the camera. While the commercial version of the product will be completely self-contained, the Phase 1 device will be controlled by a laptop computer. It will otherwise be fully functional. An initial human study will also be conducted in Phase 1. In the 3 components of the study, novice users will assess the ease-of-use of the device, patients will assess their level of comfort with the exam, and, in a blinded process, acquired images will be read by two qualified retinal specialists and compared to images acquired concurrently with a high-quality, tabletop fundus camera, to determine diabetic retinopathy screening efficacy with the prototype device.
