Retinal Imaging Using NOTAL-OCT V3.0

NCT ID: NCT04078672

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2023-03-26

Brief Summary

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)

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.

Conditions

AMD; DR

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

AMD

NOTAL-OCT V3.0 scan

Group Type: EXPERIMENTAL

NOTAL-OCT V3.0

Intervention Type: PROCEDURE

AMD and DR patients

Interventions

NOTAL-OCT V3.0

AMD and DR patients

Intervention Type: PROCEDURE

Other Intervention Names

OCT scan

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Notal Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assuta Hashalom

Tel Aviv, , Israel

Tel Aviv Medical Center

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

NOTAL-OCT V3.0

Identifier Type: -

Identifier Source: org_study_id