Retinal Imaging Using NOTAL-OCT

November 11, 2020 updated by: Notal Vision Ltd.
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intermediate AMD
Device: Notal OCT
Imaging using Notal OCT
Advanced AMD
Device: Notal OCT
Imaging using Notal OCT
DR without macular edema
Device: Notal OCT
Imaging using Notal OCT
DR with macular edema
Device: Notal OCT
Imaging using Notal OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula.
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2017

Primary Completion (Actual)

May 14, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

December 13, 2017

First Posted (Actual)

December 14, 2017

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNZ-0077-017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Macular Degeneration

Clinical Trials on Notal OCT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe