Optimize Pediatric OCT Imaging

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06139523
Status
Recruiting
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Conditions

  • Glaucoma
  • Optic Nerve Diseases
  • Retinal Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Investigational contact OCT system — DEVICE
    Theia imaging is developing handheld OCT systems bring state of the art OCT to the infant bedside. The Theia 1 widefield imaging system is a light weight, high speed (300 kHz), wide field of view (110°) OCT system that address the limitations of current commercial OCT systems. The system is cart mounted, enabling portable, bedside imaging. The system uses a 300 kHz swept source laser operating in 1060nm regime. The Theia system follows the same safety standards as all applicable laser safety standards (ANSI z80.36 or ISO 15004) as the currently approved prior OCT devices. This nearly 10-fold increase in acquisition speed dramatically reduces imaging time and enables acquisition of full retinal volumes in infants. The 110° field of view is provided via a re-usable contact lens that can be sterilized between imaging sessions.
  • Investigational noncontact OCT system: — DEVICE
    The investigational noncontact handheld OCT systems in this study is developed at Duke University as the result of collaboration between the Departments of Ophthalmology (Cynthia Toth, MD) and Biomedical Engineering (Joseph Izatt, PhD). This investigational device was previously reviewed and approved for use in adults, children, and neonates in nursery by: * Intraoperative OCT Guidance of Intraocular Surgery study's (Pro00016827) Data Safety and Monitoring Board Plus (DSMB+) (PI: Toth and Izatt) * The Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care study (Pro00069721) Data Safety and Monitoring Committee (DSMC) (PI: Toth) The systems were declared non-significant risk by the Duke University Health System (DUHS) Institutional Review Board under Pro00016827. Staff from the DUHS Clinical Engineering Department evaluated the systems and found that they meet the accepted hospital standards for electrical safety.

Study Details

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

Key Dates

Start date
Jan 24, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Group 1: Healthy adult volunteers
    Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10)
  • Arm: Pediatric participants
    Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20)

Primary Outcome Measure

Presence of abnormal retinal microanatomy as measured by OCT reading [ Time Frame: Single imaging session (day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Eye CenterDurhamNorth Carolina27710
Michelle McCall
[email protected]
9196840544
Neeru Sarin
[email protected]
9196685641
Ramiro Maldonado, MD (SUB_INVESTIGATOR)
Sasapin G Prakalapakorn, MD (SUB_INVESTIGATOR)
Mays Dairi, MD (SUB_INVESTIGATOR)
Sharon F Freedman, MD (SUB_INVESTIGATOR)
Shwetha Mangalesh, MD (SUB_INVESTIGATOR)
Lejla Vajzovic, MD (SUB_INVESTIGATOR)

Find similar trials in Durham, NC

By condition
Glaucoma
By specialty
Ophthalmology
By research site
Duke University Eye Center· Durham, NC

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