Optimize Pediatric OCT Imaging
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorDuke University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Group 1 - Healthy adult volunteers
Subject is able and willing to consent to study participation
Subject is more than 18 years of age
Healthy adult volunteers without known ocular issues other than refractive error
Disqualifiers
Group 1 - Healthy adult volunteers
Students or employees under direct supervision of the investigators
Subjects with prior problems with pupil dilation
Pregnant woman if receiving dilating drops
Trial population
Group 1 - Healthy adult volunteers (n=10). Participants over the age of 18 without known ocular issues other than refractive error. Group 2 - Pediatric participants (n=10). Participants under the age of 18 being seen at Duke Eye Center for ocular abnormailities.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Investigational contact OCT system
DeviceTheia 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:
DeviceThe 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Group 1: Healthy adult volunteers2 interventions
Group B: Pediatric participants2 interventions
Trial outcomes
Primary outcomes
1
Presence of abnormal retinal microanatomy as measured by OCT reading
Time frame
Single imaging session (day 1)2
Severity of abnormal retinal microanatomy as measured by OCT reading
Time frame
Single imaging session (day 1)3
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Time frame
Single imaging session (day 1)Sponsors and contacts
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Source ClinicalTrials.gov