NCT03531853

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

May 9, 2018

Last Update Submit

June 22, 2022

Conditions

Uveitis

Outcome Measures

Primary Outcomes (1)

  • Concordance

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

    Up to 18 months

Study Arms (1)

Imaging patients

EXPERIMENTAL

Get uveitis patients and ER patients to image their eyes

Device: hand-held swept source optical coherence tomography

Interventions

hand-held swept source optical coherence tomographyDEVICE

images the eye

Imaging patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye Diseases

Study Officials

  • Anthony Kuo, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 22, 2018

Study Start

November 14, 2018

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

June 27, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)