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Retinal Imaging Using NOTAL-OCT V2.5

NCT ID: NCT03600519

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-22

Study Completion Date

2020-01-01

Brief Summary

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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

Detailed Description

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Study population:

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

Conditions

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AMD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AMD Patients

OCT scan

NOTAL OCT V2.5

Intervention Type DEVICE

AMD Patients

Interventions

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NOTAL OCT V2.5

AMD Patients

Intervention Type DEVICE

Other Intervention Names

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OCT scan

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Notal Vision Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bnei Zion

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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BNZ-0060-18

Identifier Type: -

Identifier Source: org_study_id