Office Visit screening visit:~The 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:~a .Subject's DOB (if allowed) or age b. Gender c .Race d. Ethnicity~BCVA on both eyes on the day of the visit~Both eyes of the subject will be scanned, non-dilated, with either a commercial Zeiss Cirrus or Heidelberg Engineering Spectralis OCT device with one (1) acceptable volume scan of each eye being obtained~Both eyes of the subject that meet all screening criteria will be enrolled~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~The subject will receive a general overview of the self-operation of the Notal Home OCT at the investigational clinic facility by trained study personnel. A Notal Home OCT device is then assigned to the subject.~The subject will be reminded that the Notal Home OCT will be delivered to their home and instructed to self-image the study eye(s) daily using a Notal Home OCT device at home for 90 days.~Home Set-up with Remote Assistance (Day 0)~Following confirmation of subject eligibility at the Enrollment visit and the subject is enrolled in the study:~The subject will be contacted by the NVDC to verify their delivery address.~The device will be delivered to the subject's home, with confirmation sent back to the NVDC.~Remote support is available by the NVDC via phone during standard business hours of 8am - 6pm EST, if needed.~The subject will follow the steps detailed in the Set-up Guide included in the box~In-Home Phase (Day 0 to Day 90) Following set-up of the Notal Home OCT,~Day 0: The subject will review the tutorial and will perform one calibration session for each eye.~Day 1: The subject will perform the first self-imaging session with the Notal Home OCT on both eyes followed by automated transmission of the scans. This first session will be considered a practice session.~Days 2-90: The patient will perform one self-imaging session followed by automated transmission on both eyes at home with the Notal Home OCT each day.~If an eye cannot calibrate during 5 separate attempts or fails to test 5 consecutive times, the subject will be notified by the NVDC to discontinue self-imaging this eye. If there is a fellow eye also enrolled in the study, the fellow eye will continue~Weekly Review of Notal Home OCT Images by the PI:~The physician will review patient images on a weekly basis to perform an assessment of daily fluid status and document their observations in the CRF.~Routine Care Visits:~Routine care visits may be conducted at the investigator's discretion. The following procedures will be performed at the routine care visits: BCVA, Spectralis or Cirrus OCT, 3. Initiate treatment, if necessary, and document which anti-VEGF drug is used.~At Office Exit Visit (approximately 90 days after Day 0)~Subjects will return to the clinic for an office visit approximately ninety (90) days after the Day 0 (Home Set-up) Visit. At this visit, the exams will be conducted in the following order:~BCVA will be performed on both eyes.~Both eyes of the subject will be imaged, using a Cirrus or Spectralis OCT, and reviewed by the PI to determine fluid status.~Initiate standard of care and treatment, if necessary.~Collect AEs, if applicable.~Subject completes the Notal Home OCT Subject User Questionnaire.~Exit subject from the study.
The purpose of this study is to evaluate the ability of subjects with NV-AMD to perform sequential daily self-imaging of their eyes with the self-operated Notal Home OCT device in their homes for 90 days without on-site supervision. The study will include up to 15 subjects.