Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05417152 |
| Other study ID # |
C2021.003 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 29, 2022 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
June 2022 |
| Source |
Notal Vision Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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:
1. Patient will be informed concerning the study and sign the Informed Consent Form (ICF)
prior to conduct of any study procedures.
2. Following signing the ICF, subjects will be assigned a Subject ID by a designated staff
at the clinical site.
3. The following data will be collected for each study subject:
1. Date of birth
2. Gender
3. Number and type of Anti-VEGF injections and last injection date
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.
1. The technician will register the subject using the touchscreen of the NVHO device using
the subject's CRF number.
2. The subject will perform a self-tutorial. The training flow begins with demonstration
clips followed by a practice session. The training flow will be followed by a self-scan
that the system uses as a calibration session.
3. Following completion of the training and calibration session, the clinic technician
shall set the device for self-scanning flow. The subject will perform four (4)
unsupervised self-scans on each study eye with a rest period of ~2 minutes between
self-scans.
5. AEs, if applicable, will be collected. 6. Exit subject from the study
