Retinal Imaging Using NOTAL-OCT V2.5

AMD Clinical Trial

Official title:

Retinal Imaging Using NOTAL-OCT V2.5

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600519
• Other study ID #: BNZ-0060-18
• Status: Completed
• Start date: July 22, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2020
• Source: Notal Vision Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Study population:

1. AMD population - intermediate and advanced AMD (with active and nonactive CNV)

2. DR population. Patient with and without DME

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: January 1, 2020
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• AMD

Intervention

Device:
• NOTAL OCT V2.5
AMD Patients

Locations

Country	Name	City	State
Israel	Bnei Zion	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid	measurements of retinal thickness.	less than an hour