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

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531853
• Other study ID #: Pro00092968
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: March 10, 2021

Study information

• Verified date: June 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Uveitis

Intervention

Device:
• hand-held swept source optical coherence tomography
images the eye

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance	By the ability to detect cells in the eye compared to clinical exam	Up to 18 months