Retinal Imaging Using NOTAL-OCT V2.5

Primary objectives:

To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT.

Secondary objectives:

1. To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula.
2. To evaluate the repeatability of the NOTAL-OCT V2.5

Study Overview

• Status: Completed
• Conditions: AMD
• Intervention / Treatment: Device: NOTAL OCT V2.5

Detailed Description

Study population:

1. AMD population - intermediate and advanced AMD (with active and nonactive CNV)
2. DR population. Patient with and without DME

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3339123
    • Bnei Zion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

MAD patients

Description

1. Inclusion Criteria:

   a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) or better in SE

2. Exclusion Criteria:

   1. AMD and DR in the same SE
   2. Evidence of macular disease other than AMD or DME in SE
   3. Patient with dilated eye(s)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AMD Patients; OCT scan	Device: NOTAL OCT V2.5; AMD Patients; Other Names: OCT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid	measurements of retinal thickness.	less than an hour

Collaborators and Investigators

• Sponsor: Notal Vision Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2018
• Primary Completion (ACTUAL): February 18, 2019
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: BNZ-0060-18

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