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OpenTrials
Completed

NCT Number: NCT03600519

Retinal Imaging Using NOTAL-OCT V2.5

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

Completed

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Key information

Conditions

AMD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bnei Zion

Haifa, 3339123, Israel

About this study

Study population:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NOTAL OCT V2.5

Device

AMD Patients

Other names: OCT scan

Primary outcomes

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

    Time frame: less than an hour

    measurements of retinal thickness.

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 26, 2018
Registry last updated
Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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