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OpenTrials
Completed

NCT Number: NCT03374020

Retinal Imaging Using NOTAL-OCT

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

Completed

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Key information

Conditions

Age-Related Macular Degeneration Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability and agreement to give informed consent (IC)
  • Diagnosis of AMD or DR in SE by OCT
  • Ability to undergo OCT scans
  • VA of 20/160 or better in SE

Exclusion criteria

  • AMD and DR in the same SE
  • Evidence of macular disease other than AMD or DME in SE

Treatment and study plan

Notal OCT

Device

Imaging using Notal OCT

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 14, 2017
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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