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Completed

NCT Number: NCT04078672

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)

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Key information

Conditions

AMD DR

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assuta Hashalom, Tel Aviv, Israel

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About this study

4.5.1 SCREENING VISIT:

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

  • Patient will sign the IC (Informed Consent) form
  • Test the eligible eye(s) of the patient will be tested
  • The following demographic and clinical data will be collected for each tested eye and will be registered in the CRF:
  • Patient's DOB and gender.
  • Patient's diagnosis in study eye(s), based on patient's medical record, including media opacity (e.g. cataract or corneal opacity, if exists).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NOTAL-OCT V3.0

Procedure

AMD and DR patients

Other names: OCT scan

Primary outcomes

  1. To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and by a commercial OCT

    Time frame: 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 outcomes

  1. To evaluate the level of agreement between OCT images captured by NOTAL-OCT V3.0 and a by commercial OCT

    Time frame: 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

    Time frame: 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

    Time frame: Less then an hour

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

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2019
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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