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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2021-03-10

Brief Summary

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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).

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Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Imaging patients

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Group Type EXPERIMENTAL

hand-held swept source optical coherence tomography

Intervention Type DEVICE

images the eye

Interventions

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hand-held swept source optical coherence tomography

images the eye

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes