Retinal Imaging Using NOTAL-OCT V3.0

The study will include up to 250 AMD patients and up to 30 DR patients. In Tel Aviv medical center up to 100 AMD/ 20 DR patients will be recruited; In Assuta HaShalom up to 100 AMD/10 DR patients will be recruited; In Bnei Zion medical center up to 50 AMD patients will be recruited.

4.1 Study population 1. AMD patients - intermediate and advanced AMD (with active or non-active CNV) 2. DR patients - with and without edema 4.2 Inclusion criteria

1. Ability and agreement to give informed consent (IC)
2. Diagnosis of AMD or DR in SE by OCT
3. Ability to undergo OCT scans
4. VA of 20/400 (6/120) or better in study eye(s)

4.3 Exclusion criteria

1. Patient with dilated eye(s)

Study Overview

• Status: Completed
• Conditions: AMD; DR
• Intervention / Treatment: Procedure: NOTAL-OCT V3.0

Detailed Description

4.5.1 SCREENING VISIT:

For patients eligible to participate in the study, the following procedure will be done in the screening visit:

1. Patient will sign the IC (Informed Consent) form
2. Test the eligible eye(s) of the patient will be tested

3. The following demographic and clinical data will be collected for each tested eye and will be registered in the CRF:

   1. Patient's DOB and gender.
   2. Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
   3. Examination to check habitual correction, pinhole VA and refraction.

   4.5.2 OCT Visit 1: may take place on the same day as screening visit.

   For each eligible eye, testing will include:

   d. Refraction by auto-refractometer e. Commercial OCT scanning: i. Scanning pattern: Macular cube of at least 6mm (20 degrees); At least 40 B-scans per cube f. NOTAL-OCT V3.0 scanning: i. Scanning pattern Macular cube of the central 10 degrees of the macula At least 40 B-scans per cube ii. The patients will undergo an interactive tutorial that will teach the patient to self-operate the NOTAL-OCT V3.0 device. The tutorial will be done only once, using the eye with the better VA.

   iii. To check repeatability, image capturing phase will include up to 8 testing sessions, each ~2 minutes long.

   iv. Patients will rest for 5 minutes between sessions. v. Total examination time with NOTAL-OCT V3.0 is expected to be less than an hour.

   vi. In case of patient's fatigue during the testing procedure, examination session will be terminated.

   vii. The study staff will administer the NOTAL-OCT V3.0 "patient-experience" questionnaire at the 1st OCT Visit.

   4.5.3 OCT Visits 2-6:

   For each eligible eye, imaging will include:

   a. Commercial OCT scanning: i. Scanning pattern: Macular cube of at least 6mm (20 degrees); At least 40 B-scans per cube b. NOTAL-OCT V3.0 scanning: i. Scanning pattern Macular cube of the central 10 degrees of the macula At least 40 B-scans per cube ii. Image capturing phase that will include up to 8 testing sessions, each a~2 minutes long.

   iii. Patients will rest for 5 minutes between sessions. iv. Total examination time with the NOTAL-OCT V3.0 is expected to be less than an hour.

   v. In case of patient's fatigue during the testing procedure, examination will be terminated.

   c. VA of eye(s) participating in the study. d. Clinical diagnosis of eye(s) participating in the study.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Medical Center
  • Tel Aviv, Israel
    • Assuta HaShalom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1. Ability and agreement to give informed consent (IC) 2. Diagnosis of AMD or DR in SE by OCT 3. Ability to undergo OCT scans 4. VA of 20/400 (6/120) or better in study eye(s)

Exclusion Criteria:

• 1. Patient with dilated eye(s)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMD; NOTAL-OCT V3.0 scan	Procedure: NOTAL-OCT V3.0; AMD and DR patients; Other Names: OCT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT	The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.	Less then an hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT	The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.	Less then an hour
To evaluate repeatability	To evaluate the repeatability of the detection of fluid in images captured by NOTAL-OCT V3.0 in the central 10 degrees of the macula of AMD and DR patients.	Less then an hour
To evaluate the level of agreement between NOTAL-OCT V3.0 and a commercial OCT in the presence of fluid	The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula.	Less then an hour

Collaborators and Investigators

• Sponsor: Notal Vision Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): March 26, 2023

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NOTAL-OCT V3.0

Drug and device information, study documents

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