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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03531853
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Actual Duration (Months): 27.8
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Uveitis	Device: hand-held swept source optical coherence tomography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
• Actual Study Start Date: Nov 14, 2018
• Actual Primary Completion Date: Mar 10, 2021
• Actual Study Completion Date: Mar 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Imaging patients Get uveitis patients and ER patients to image their eyes	Device: hand-held swept source optical coherence tomography; images the eye

Outcome Measures

Primary Outcome Measures

1. Concordance [Up to 18 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Anthony Kuo, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03531853
• Other Study ID Numbers: Pro00092968
• First Posted: May 22, 2018
• Last Update Posted: Jun 27, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Uveitis

Study Results

No Results Posted as of Jun 27, 2022