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The study will enroll up to 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at 1 site in the United States. Subjects must meet all inclusion and no exclusion criteria.
Description of Study Procedures and In-Office Visit:
Enrollment/Screening:
At the Enrollment/ Screening Visit, the exams will be conducted in the following order:
Patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures.
The following data will be collected for each study subject:
The following data will be collected for the study eye:
i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings, e.g., epi retinal membrane, macular hole, vitreo-macular traction (VMT)
Refraction correction
Snellen BCVA on both eyes on the day of the visit.
Selecting the study eye:
NOTE: Any planned treatment for NV-AMD should be administered after completion of all study-related scans
OCT Scans:
The study eye of the subject will be scanned once, non-dilated, with a Zeiss Cirrus OCT device to get an acceptable single volume scan of the study eye in each repetition.
Scanning pattern to be used: Macular cube, 6X6mm, 128 B-scans per volume scan
Following the Zeiss Cirrus OCT scans, the subject will be placed in a room with the Notal OCT V3.0 device which has been set up by a technician.
Notal OCT V3.0 scans
Collect AEs, if applicable.
Exit the subjects from the study.
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| Measure | Description | Time Frame |
|---|---|---|
| Notal Home OCT Total Retinal Fluid (TRF) amount measured by NOA | volume [nl] of the TRF | 5 minutes |
| Notal Home OCT Intra-Retinal Fluid (IRF) amount measured by NOA | volume [nl] of the IRF | 5 minutes |
| Notal Home OCT Sub-Retinal Fluid (SRF) amount measured by NOA | volume [nl] of the SRF | 5 minutes |
| Zeiss Cirrus OCT Total Retinal Fluid (TRF) amount measured by a human reader | volume [nl] of the TRF | 5 minutes |
| Zeiss Cirrus OCT Intra-Retinal Fluid (IRF) amount measured by a human reader | volume [nl] of the IRF | 5 minutes |
| Zeiss Cirrus OCT Sub-Retinal Fluid (SRF) amount measured by a human reader | volume [nl] of the SRF | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects who completed self-scanning on the Notal Home OCT, following a self-tutorial. | Number of subjects and percentage of subjects who completed self-scanning on the Notal Home OCT, following a self-tutorial. | 5 minuts |
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Inclusion Criteria:
Exclusion Criteria:
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30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at one 1 site in the United States.
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| Name | Affiliation | Role |
|---|---|---|
| Gidi Benyamini | Notal vision Druyanov 5, Tel Aviv | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elman Retina Group | Glen Burnie | Maryland | 21061 | United States |
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