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The Foresce Home is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.

The Foresee Home system is an interactive software driven device that provides a series of linear images to the macular and peri-macular region of the eye. The changes in macular and near macular function can be quantified by the device thus enabling the reader to detect early changes in macular degeneration and associated diseases to allow earlier intervention. The Foresee Home applies the concept of the static and automated perimeter in the detection of visual field defects. The technology, based on hyperacuity, is used for highly specific quantification of central and paracentral visual fields defects. Hyperacuity (also termed "Vernier acuity") is defined as the ability to perceive a difference in the relative spatial localization of two or more visual stimuli. Hyperacuity threshold may be as low as 3-6 sec of arc and the hyperacuity stimuli are highly resistant to retinal image degradation and thus suitable for assessing retinal function in patients with opaque media as well. Retinal pigment epithelium (RPE) elevation, such as that which occurs in AMD, causes a shift in the regular position of photoreceptors. It is hypothesized that such a shift causes an object to be perceived at a different location from its true location in space. The analysis engine of the device tries to define areas in the visual field that are suspected as being related to CNV. Such areas are called CNV related zones. Although these zones are called 'CNV-related,' they simply indicate areas of greater metamorphopsia and can often occur in non-CNV lesions." Note that the response on this indicator is only indicative of the presence or absence of significant metamorphopsia that may exist in conditions NOT associated with CNV (such as geographic atrophy or drusen). The Foresee Home is intended to be used in a home environment following training given by a qualified healthcare professional. The user interface and interaction with the device is similar to office Preview PHP. The results of each testing session, the test reports, similar to these generated by the Preview PHP system, will be transmitted electronically directly to the healthcare professional. Test reports will not be displayed on the monitor in the patient's home, but rather will be used by the healthcare professional in the same fashion as it is currently employed with the in-office Preview PHP. Thus, the only difference between the Preview PHP system and the Foresee Home is that the Foresee Home unit is placed in the patient's home environment to facilitate testing and the test report is then transmitted to the healthcare professional. It should be noted that the Foresee Home is not intended to provide automated interpretation, evaluation, treatment decisions, or to be used as a substitute for professional healthcare judgment.