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The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.
Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Self trained subjects | ||
| 2 | supervised trained subjects |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who managed to set the device | 6 months | |
| Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training | 6 month | |
| Number of device malfunctions | 6 month | |
| Average use of the device | 6 month |
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Inclusion Criteria:
Capable and willing to sign a consent form and participate in the study
Exclusion Criteria:
Evidence of macular disease other than AMD or glaucoma in the study eye
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Subjects diagnosed as Intermediate AMD
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| Name | Affiliation | Role |
|---|---|---|
| Haya Morori Katz, M.D. | Kaplan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | Israel | ||||
| Kaplan Medical Center |
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| Label | URL |
|---|---|
| sponsor site | View source |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| Rehovot |
| Israel |
| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |