Single In-Clinic Encounter With the Notal Vision Home OCT

Office Visit:

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
• The following data will be collected for each study subject:

• Subject's DOB (if allowed) or age
• Gender
• Number and type of injections and last injection date
• Refraction correction
• Snellen BCVA on both eyes on the day of the visit.
• Eligible eyes of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device 3 times with one (1) acceptable volume scan of each eye being obtained.

Scanning pattern to be used:

a. Macular cube, 6X6mm, 128 B-scans per volume scan NOTE: Any planned treatment for NV-AMD should be administered after completion of all study-related scans.

• Eyes of the subject that meet all screening criteria will be enrolled. NOTE: All enrolled subjects should have at least one eye with active CNV (i.e., with SRF and/or IRF) confirmed by commercial OCT scan(s) at the time of enrollment 7. The following data will be collected for the study eye(s):

• Qualifying diagnosis for the study eye from the subject's medical record
• 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 clinic technician.

• The clinic technician will register the subject using the touchscreen of the NVHO device.
• The subject will perform a self-tutorial, without any help from the clinic's staff. The training flow begins with demonstration clips followed by a practice phase. The training flow will be followed by a self-scan that the system uses as a calibration session.

Note: If an eye cannot calibrate during 3 separate attempts or fails to test 3 consecutive times, the subject will discontinue self-imaging in this eye. If there is a fellow eye also enrolled in the study, the fellow eye will continue.

• Following completion of the training and calibration session, the clinic technician sets the device for testing flows. The subject will perform three (3) unsupervised self-scans on each study eye with a rest period of ~5 minutes between self-scans. In case of scan failures, the user will perform up to 3 additional attempts to complete the required 3 self-scans. The number of attempts will not exceed 3 times per study eye.
• At the end of each self-scanning, and during the 5-minute resting period, image results will be automatically uploaded to Notal Health Cloud.

NOTE: Support provided by the sponsor will be available to study subjects throughout the study including tutorial, calibration and scanning, if needed.

• Once the subject completes the testing session in its entirety, the subject will be asked to complete a questionnaire about their experience as a user of the NVHO device and proposed naming options for the device.
• Collect AEs, if applicable.
• Exit the subjects from the study.
• Self-scan data will be backed up on the NVHO device. Commercial Cirrus OCT data will be copied to an external drive and sent to a Notal repository. Study visit data and subject questionnaires responses will be entered into a Sponsor-provided CRF and sent to a Notal repository.

Inclusion criteria

• Ability to speak, read and understand English.
• Ability to understand and agree to contents of informed consent either in writing or verbally.
• Eighteen (18) years of age or older at the time of Informed Consent.
• AMD patients diagnosed with wet NV-AMD in at least one eye (ie, with SRF, and/or IRF).
• Fellow eye with NV-AMD (with or without fluid) or intermediate AMD.
• Best corrected Visual Acuity of 20/320 or better in eyes participating at the study.

Exclusion criteria

• Subjects with dilated pupils.
• Any other retinal disease requiring steroidal or anti-VEGF injections.