Home OCT Repeatability and Reproducibility of Automatic Fluid Quantification Study

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.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration

Detailed Description

Description of Study Procedures and In-Office Visit:

Enrollment/Screening:

At the Enrollment/ Screening 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. The following data will be collected for each study subject:

   1. Subject's DOB
   2. Gender
   3. Number and type of injections and last injection date

3. The following data will be collected for the study eye:

   1. Qualifying diagnosis for the study eye from the subject's medical record
   2. 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)

4. Refraction correction
5. Snellen BCVA on both eyes on the day of the visit.

6. Selecting the study eye:

   1. Both eyes of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device to get an acceptable single volume scan per eye. Scanning pattern to be used: Macular cube, 6X6mm, 128 B-scans per volume scan
   2. The PI/CoPI will read the Zeiss Cirrus OCT scans of both eyes and will grade each eye for the presence/absence of SRF and/or IRF in the retina
   3. The eye with SRF and/or IRF will be set as the study eye. In case both eyes were graded as fluid-present, the study eye will be set randomly
   4. The Zeiss Cirrus OCT scan of the study eye will be part of the study analysis

NOTE: Any planned treatment for NV-AMD should be administered after completion of all study-related scans

OCT Scans:

1. 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

2. 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.

3. Notal OCT V3.0 scans

   1. The technician will register the subject using the touchscreen of the Notal OCT V3.0 device and the assigned Subject ID.
   2. On the first Notal OCT V3.0 device the subject will perform a self-tutorial.
   3. The technician will set the first Notal OCT V3.0 for self-scan of the study eye. The subject will perform the tutorial on the eye with better vision, based on the subject's subjective decision, even if that eye is not the study eye. Then, the subject will perform on the first device- a calibration, and 5 volume scans.
   4. The technician will set the second device for self-scans of the study eye. The subject will perform calibration and 5 volume scans.
   5. The subject will be able to rest 1-2 minutes between self-scans
4. Collect AEs, if applicable.
5. Exit the subjects from the study.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Glen Burnie, Maryland, United States, 21061
      • Elman Retina Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Ability to speak, read and understand English.
2. Ability to understand and agree to contents of informed consent in writing or verbal.
3. Adult diagnosed with NV-AMD in at least one eye based on the subject's medical record.
4. Fluid presence in the study eye per the PI review of Screening commercial OCT.
5. Best corrected Visual Acuity of 20/320 or better in the study eye.
6. Available and willing to conduct self-scanning in the office

Exclusion Criteria:

1. Any other retinal disease requiring steroidal or anti-VEGF injections.
2. Dilated pupils

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Notal Vision Inc.
• Investigators: Study Chair: Gidi Benyamini, Notal vision Druyanov 5, Tel Aviv

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: C2021.002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No