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OpenTrials
Completed

NCT Number: NCT03323307

Low Cost OCT for Point of Care

The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.

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Key information

Conditions

Optical Coherence Tomography (OCT) of the Retina Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Ornithine Carbamoyltransferase Deficiency Disease Urea Cycle Disorders, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina Kittner Eye Center

Chapel Hill, North Carolina, 27517, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled to receive standard OCT testing as part of their clinical visit

Exclusion criteria

  • none

Treatment and study plan

OCT imaging

Device

imaging of retina using OCT device

Primary outcomes

  1. Number of Participants With Acceptable OCT Image Quality

    Time frame: day 1

    measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device

Secondary outcomes

  1. Central Macular Thickness

    Time frame: day 1

    compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system

  2. Total Macular Volume

    Time frame: day 1

    compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • University of North Carolina, Chapel Hill
  • Wallace H. Coulter Foundation

Registry information

Official study title

Low Cost Optical Coherence Tomography for Point of Care

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2017
Registry last updated
Dec 5, 2019

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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