Retinal Imaging Using NOTAL-OCT V2.5

Completed

• Conditions: AMD
• Interventions: Device: NOTAL OCT V2.5

• Registration Number: NCT03600519
• Lead Sponsor: Notal Vision Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study Start: 2018-07-22
• Study First Posted: 2018-07-26
• Primary Completion: 2019-02-18
• Study Completion: 2020-01-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMD Patients	NOTAL OCT V2.5	OCT scan

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bnei Zion; 🇮🇱 Haifa, Israel