NCT03600519

Brief Summary

Primary objectives: To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT. Secondary objectives:

  1. 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. 2.To evaluate the repeatability of the NOTAL-OCT V2.5

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 13, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

July 17, 2018

Last Update Submit

November 11, 2020

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

  • The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid

    measurements of retinal thickness.

    less than an hour

Study Arms (1)

AMD Patients

OCT scan

Device: NOTAL OCT V2.5

Interventions

NOTAL OCT V2.5DEVICE

AMD Patients

Also known as: OCT scan
AMD Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MAD patients

You may qualify if:

  • 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

You may not qualify if:

  • AMD and DR in the same SE
  • Evidence of macular disease other than AMD or DME in SE
  • Patient with dilated eye(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnei Zion

Haifa, 3339123, Israel

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

July 22, 2018

Primary Completion

February 18, 2019

Study Completion

January 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-10

Locations

IL(1)