[0011]This invention features a simple, compact, low-cost screening device targeted toward medical practitioners with little or no prior experience with
retinal imaging or imaging of the external
auditory canal. The market for such devices is likely to grow in size as the shift toward lower-cost medical providers continues, driven by the managed care industry. An aging
population, and rapidly growing incidence of diabetes also drive this market. Primary care physicians are called on more frequently to do the work of specialists, and nurse practitioners are taking on more of the duties of doctors, including seeing patients. Doctors will continue to surrender more of their traditional duties to less-skilled staff and will assume more of a care manager and advisory role for their patients. It is important for
medical device developers to keep this trend in mind in order to place the proper emphasis on ease of use and simplicity of their devices, especially those intended for use by non-specialists. Since it is clear in the case of
diabetic retinopathy screening that the best chance of maximizing the diagnosis of
retinal disorders is through screening within the primary
care setting, the invention provides for increased access to screening for the populations that need it the most. In rural and underserved areas where the lack of specialists coincides with the lowest rate of screening, highest risk of undetected
diabetic eye disease, and the least amount of resources to buy large and expensive equipment, the small, low-cost inventive digital ophthalmoscope provides a promising means to decrease the incidence of
blindness and vision loss among diabetics.
[0012]The inventive handheld, battery-powered device acquires images of the
retina. The images can be transmitted from the examination site to an expert reading center via a standard
telephone line, cellular link, or Internet connection. An expert consultant can then view the images on a high-resolution color monitor. The images may be compared to previous images stored for that particular patient, or to a
library of standard diagnostic images. A diagnostic response may be made back to the referring party within minutes, either by telephone, fax,
pager, or e-mail. If evidence of retinal
abnormality is seen, the patient may be referred to an ophthalmologist for a complete mydriatic exam and follow-up treatment. For the
primary care physician, routine screening of high-risk patients may be offered economically. The periodic monitoring of known diabetic patients will improve their
standard of care and reduce medical costs by detecting ocular problems at an early, treatable stage. The device may also be used as part of a routine
physical exam, and may be able to identify previously undiagnosed diabetics by means of
diabetic retinopathy. Some patients already have detectable
diabetic retinopathy by the time a diagnosis of diabetes is made. An eye exam included as part of a routine physical may also allow other eye diseases to be detected earlier and referred to an ophthalmologist, since patients with no perceived visual problems are not as likely to have regular eye exams.
[0013]In addition to the telemedicine service, image data can also be output from the inventive device in standard file formats for storage in any
personal computer. Data formats can be compatible with emerging Picture Archiving and Communication Systems (PACS) standards such as the
Digital Imaging and Communication in
Medicine (
DICOM) standard, enabling integration with the user's medical management
software. Optional color printers may be used to produce
hard copy records of the images for inclusion in paper records, to give to the patient, or to provide to another consulting practitioner. The ability to store images is important in order for a healthcare worker to quickly assess
disease progression. There is a great opportunity for the advancement of scientific knowledge by having access to larger numbers of retinal images for research purposes.