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

Not Applicable

Completed

• Conditions: Uveitis
• Interventions: Device: hand-held swept source optical coherence tomography

• Registration Number: NCT03531853
• Lead Sponsor: Duke University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2018-11-14
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Imaging patients	hand-held swept source optical coherence tomography	Get uveitis patients and ER patients to image their eyes

Primary Outcome Measures

Name	Time	Method
Concordance	Up to 18 months	By the ability to detect cells in the eye compared to clinical exam

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States