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In this clinical study the Notal Vision Home OCT (NVHO) Monitoring System will be used to evaluate the ability of patients diagnosed with DME to perform sequential self-images of their eyes with the self-operated NVHO device in a home simulated environment in the doctor's office.
The study population will include up to 30 patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one site in Israel.
Office Visit NOTE: Any planned treatment for DME at the day of the study should be administered after completion of all study-related scans
At the enrollment Office 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.
Following signing the ICF, subjects will be assigned a Subject ID by a designated staff at the clinical site.
The following data will be collected for each study subject:
3. Refraction correction 4. Snellen BCVA on both eyes on the day of the visit. 5. Eligible eye(s) of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device with one (1) acceptable volume scan of each eye being obtained out of up to 3 attempts.
Scanning pattern to be used:
Macular cube, 6X6mm, 128 B-scans per volume scan 6. Eyes of the subject that meet all screening criteria will be enrolled. If both eyes of the subjects meet all screening criteria both eyes will be enrolled.
NOTE: Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
7. The following data will be collected for the study eye(s):
a. Qualifying diagnosis for the study eye from the subject's medical record b. From the subject's medical record, the presence of other ophthalmic conditions including but not limited to: i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings, e.g., epi retinal membrane, macular hole, vitreo-macular traction (VMT)
Following confirmation of subject eligibility, subject will be placed in a room with the NVHO device which has been set up by a technician.
5. AEs, if applicable, will be collected. 6. Exit subject from the study
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| Measure | Description | Time Frame |
|---|---|---|
| NVHO Total Retinal Fluid (TRF) | volume (nl) measured by NOA (automatic OCT analyzer) | 5 minutes |
| NVHO Intra-Retinal Fluid (IRF) | volume (nl) measured by NOA (automatic OCT analyzer) | 5 minutes |
| NVHO Sub-Retinal Fluid (SRF) | volume (nl) measured by NOA (automatic OCT analyzer) | 5 minutes |
| Zeiss Cirrus OCT Total Retinal Fluid (TRF) | volume (nl) measured by a human reader | 10 minutes |
| Zeiss Cirrus OCT Intra-Retinal Fluid (IRF) | volume (nl) measured by a human reader | 10 minutes |
| Zeiss Cirrus OCT Sub-Retinal Fluid (SRF) | volume (nl) measured by a human reader | 10 minutes |
| Scanning session completion status | complete/incomplete | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include up to thirty (30) patients, with DR in at least one eye at the time of enrollment. All subjects will be enrolled at one (1) site in Israel. The subjects must meet all inclusion / exclusion criteria. Approximately 90% of the enrolled subjects should have at least one eye with DME at the time of enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assuta Hashalom | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |