Back to resultsOCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
Primary Purpose
Uveitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hand-held swept source optical coherence tomography
Sponsored by
About this trial
This is an interventional device feasibility trial for Uveitis
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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Imaging patients
Arm Description
Get uveitis patients and ER patients to image their eyes
Outcomes
Primary Outcome Measures
Concordance
By the ability to detect cells in the eye compared to clinical exam
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03531853
Brief Title
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
Official Title
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 14, 2018 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
March 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaging patients
Arm Type
Experimental
Arm Description
Get uveitis patients and ER patients to image their eyes
Intervention Type
Device
Intervention Name(s)
hand-held swept source optical coherence tomography
Intervention Description
images the eye
Primary Outcome Measure Information:
Title
Concordance
Description
By the ability to detect cells in the eye compared to clinical exam
Time Frame
Up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Kuo, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OCT Technology Development to Assess Ocular Integrity and Characterize Ocular Integrity and Intraocular Scatterers
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