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Retinal Imaging Using NOTAL-OCT V3.0

Sponsor
Notal Vision Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04078672
Collaborator
(none)
280
Enrollment
2
Locations
1
Arm
48.9
Anticipated Duration (Months)
140
Patients Per Site
2.9
Patients Per Site Per Month

Study Details

Study Description

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)
Condition or Disease Intervention/Treatment Phase
  • Procedure: NOTAL-OCT V3.0
 N/A

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:

  4. Patient's DOB and gender.

  5. Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).

  6. 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:
  1. 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.

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

  2. 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.

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

  4. 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:
  1. 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.

  1. 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.

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

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Retinal Imaging Using NOTAL-OCT V3.0
Actual Study Start Date :
Dec 2, 2019
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMD

NOTAL-OCT V3.0 scan

Procedure: NOTAL-OCT V3.0
AMD and DR patients
Other Names:
  • OCT scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT [Less then an hour]

      The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.

    Secondary Outcome Measures

    1. To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT [Less then an hour]

      The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula of DR patients.

    2. To evaluate repeatability [Less then an hour]

      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.

    3. To evaluate the level of agreement between NOTAL-OCT V3.0 and a commercial OCT in the presence of fluid [Less then an hour]

      The measurement of fluid as identified by an eye-care professional, in the central 10 degrees of the macula.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assuta Hashalom Tel Aviv Israel
    2 Tel Aviv Medical Center Tel Aviv Israel

    Sponsors and Collaborators

    • Notal Vision Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Notal Vision Ltd.
    ClinicalTrials.gov Identifier:
    NCT04078672
    Other Study ID Numbers:
    • NOTAL-OCT V3.0
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Aug 3, 2022