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| ID | Type | Description | Link |
|---|---|---|---|
| WIRB Pr. No.: 20071980 |
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The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .
Stage I:
This stage will be completed within 1 to 5 visits, depending on personal progress rate.
Subjects who have successfully completed stage I will be recruited to stage II.
Those subjects will:
• Perform 3 tests , each test in a different day
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who successfully set up the device | 1 month | |
| Proportion of subjects who successfully pass the training program (successful calibration module) | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with reliable tests results | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited in community centers and clinics and will include up to 25 people aged >50 years (Age-related Macular Degeneration age group). The group will be heterogeneous in terms of education, age, ethnic background, and gender. The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study
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| Name | Affiliation | Role |
|---|---|---|
| Adam Mr Weinstein, MD | Kidney Health Center of Maryland | Principal Investigator |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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