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Clinical Trials/NCT03531853
NCT03531853
Completed
Not Applicable

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

Duke University1 site in 1 country14 target enrollmentNovember 14, 2018
ConditionsUveitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Uveitis
Sponsor
Duke University
Enrollment
14
Locations
1
Primary Endpoint
Concordance
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
November 14, 2018
End Date
March 10, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Concordance

Time Frame: Up to 18 months

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

Study Sites (1)

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