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NCT03600519 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design

Related Conditions & MeSH terms

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
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