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OpenTrials
Completed

NCT Number: NCT03531853

OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers

The purpose of this study is to develop and demonstrate new technologies that will enable a non-contact, compact eye imaging system based on OCT to assist an early responder in acute care settings (like an emergency room) to help assess eye trauma and inflammation (swelling inside the eye).

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pre-clinical: employees or students (over the age of 18) of the Duke Eye Center or Biomedical Engineering willing to be imaged with OCT system
  • Pilot (ER): patients (over the age of 18) presenting emergently to the Duke Emergency room with traumatic eye injuries and/or suspected open globe
  • Pilot (Uveitis): patients presenting to the Duke Eye Center with active uveitis and microhyphema or hyphema; patients who have independently consented to undergo vitreous tap or biopsy for their uveitis care at the Duke Eye Center

Exclusion criteria

  • Pre-clinical: subject cannot be a direct report to any of the PIs or other key personnel of this study
  • Pilot (ER): hemodynamically unstable, unable to consent
  • Pilot (Uveitis): unable to consent; cornea or lens opacity/scar which would block the imaging modality

Treatment and study plan

hand-held swept source optical coherence tomography

Device

images the eye

Primary outcomes

  1. Concordance

    Time frame: Up to 18 months

    By the ability to detect cells in the eye compared to clinical exam

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 22, 2018
Registry last updated
Jun 27, 2022

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.

Published trials that share one or more normalized conditions with this study.