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NCT03374020 Clinical Trial

Retinal Imaging Using NOTAL-OCT

Diabetic Retinopathy Clinical Trial

Official title:
Retinal Imaging Using NOTAL-OCT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03374020
Other study ID # BNZ-0077-017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 17, 2017
Est. completion date December 1, 2018

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

Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date December 1, 2018
Est. primary completion date May 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 20/160 or better in SE Exclusion Criteria: 1. AMD and DR in the same SE 2. Evidence of macular disease other than AMD or DME in SE

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Notal OCT
Imaging using Notal OCT

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Notal Vision Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula. OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision "there is fluid" or "there is no fluid" will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared 1 year
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