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The Macular Integrity Assessment (MAIA™) is indicated for measuring macular sensitivity, fixation stability and the locus of fixation, as well as providing infrared retinal imaging. It contains a reference database that is a quantitative tool for the comparison of macular sensitivity to a database of known normal subjects.

The MAIA™ is a confocal, line scanning, infrared, ophthalmoscope, combined with a system for visible light projection to obtain perimetric measurements, using "fundus perimetry" (also "microperimetry"). MAIA™ integrates in one device an automated perimeter and an ophthalmoscope, providing: - images of the central retina over a field of view of 36° x 36°, acquired under infrared . illumination; - recordings of eye movements obtained by "tracking" retinal details in the live retinal images and . providing a quantitative analysis of fixation characteristics; - measurements of differential light sensitivity (or threshold sensitivity) at multiple locations in . the macula, obtained by recording a patient's subjective response (see / don't see) to a light stimulus projected at a certain location over the retina; - comparison of measured threshold sensitivity with a reference database obtained from normal . subjects, indicating whether measured thresholds are above or below certain percentiles. MAIA 100 works with no pupil dilation (non-mydriatic). MAIA™ integrates a computer for control and data processing and a touch-screen display and it is provided with a power cord and a push-button. MAIA™ works with a dedicated software application running on a custom Linux O.S.

The Guided Progression Analysis for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II- i series is a software analysis module that is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma. It is also intended to compare change over time and determine if statistically significant change has occurred. The Carl Zeiss Meditec, Inc. Guided Progression Analysis is a software analysis module for the Humphrey® Field Analyzer II (HFA II) and Humphrey® Field Analyzer II - i series (HFA II - i) that assists practitioners with the detection, measurement, and management of progression of visual field loss. It aids in assessing change over time, including change from baseline and rate of change. It is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, glaucoma.

The Carl Zeiss Meditec, Inc. Guided Progression Analysis (GPA) is a software package for the Humphrey Field Analyzer II and II - i series that is designed to help practitioners identify progressive visual field loss in glaucoma patients. GPA compares the visual field test results of up to 14 follow-up tests to an established baseline over time and determines if there is statistically significant change. The GPA printout highlights any changes from baseline that represent larger than expected clinical variability, and it provides simple plain-language messages such as "Possible Progression" or "Likely Progression" whenever changes show consistent and statistically significant loss. The GPA printout also presents the Visual Field Index (VFI), a global index which reports a measure of the patient's remaining useful vision in the form of a percentage, as well as the VFI Rate of Progression plot which provides a trend analysis of the patient's overall visual field history and indicates a 3-5 year projection of the VFI regression line if the current trend continued.

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.

The TrueField Analyzer is an automated perimeter used to aid in measurement of visual field abnormalities. For the assessment of visual field abnormalities.

The TrueField Analyzer is an automated perimeter that is used to aid in measurement of visual field abnormalities. It is an objective device that monitors involuntary responses in the patient's pupils to a series of multi-focal visual stimuli presented to the eyes. The system presents stimuli and monitors the pupil responses in both eyes independently and concurrently. The device includes: - a bilateral image display system for providing individual visual stimulus to the patient's eyes (both eyes are concurrently and independently stimulated) - A pair of video cameras for monitoring the patient's pupils again concurrently and independently - A personal computer equipped to run Windows XP Professional Service Pack 2 operating system. - The TrueField Software system. The TrueField Software automatically manages the stimulus presentation and video data acquisition, ensuring synchronization between the display and video image acquisition; data analysis, storage and presentation of results for review. The TrueField Analyzer uses a different fundamental technology to the predicate device. It combines standard multi-focal stimulus and analysis technology (as used in other perimetry devices, for example K003442, K983983) with computerized pupil monitoring (for example K920937) allowing the device to objectively measure the visual field map of a patient. In doing so it is substantially equivalent to the predicate device (K954167).

The PreView PHP™ is intended for use in the detection and monitoring the progression of Agerelated Macular Degeneration (AMD) including, but not limited to, the detection of choroidal neovascularization (CNV). The PreView Preferential Hyperacuity Perimeter (PreView PHP™) 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 progression of assouse ration (CNV). It is intended to be used in the office of a licensed eye care practitioner in patients with stable fixation.

The PreView PHP™ system is an interactive software driven device that provides a series of horizontal and vertical linear images to the macular region of the eye to detect abnormalities of the central and paracentral visual field that will detect and monitor progression of age related macular degeneration including detection of choroidal neovascularization. The changes in macular and near macular function are identified by the device thus enabling the reader to detect intermediate and advancing changes in macular degeneration and associated diseases to provide the capability for earlier intervention. The PreView PHP™ is a specialized perimeter, and applies the concept of the static and automated permeter in the detection of visual field defects. The device incorporates the theory of hyperacuity to address more highly specific central and paracentral visual fields. Because of hyperacuity, perception of more finite relative spatial localization. Hyperacuity is defined as the ability to perceive a difference in the relative spatial localization of points on the central field, more specific distortions or misalignments within the central and paracentral field can be mapped with greater accuracy. The device monitors and manages the progressive changes associated with advancing macular degeneration and differentiates the different stages of AMD including but not limited to choroidal neovascularization. The PreView PHP™ system is designed for use with standard off-the-shelf PC units in the office of the practitioner. It is aimed to detect advancing changes of AMD-related lesions including but not limited to choroidal neovascularlization.

NovaVision™ is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.

NovaVision™ consists of two computer software programs: (1) one intended for health care professionals - for the precise diagnosis of patients' visual deficiencies, the development of patient-specific therapy programs, and the analysis of results of patient therapy (NovaVision™ Diagnosis Software and Training Program); and (2) one intended for patients - therapeutic software for use by patients in their homes to train and improve impaired visual functions (NovaVision™-Therapy).

The Kasha Visual Field System should be used to test the visual field of the human eye.

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