RecruitingNCT06139523

Optimize Pediatric OCT Imaging

Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study

Sponsor

Duke University

Enrollment

30 participants

Start Date

Jan 24, 2024

Study Type

OBSERVATIONAL

Conditions

Retinal Disease Glaucoma Optic Nerve Diseases

Summary

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

Inclusion Criteria9

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
Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential
Group 2 - Pediatric participants
Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
Parent/legal guardian is able and willing to consent to study participation
Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center

Exclusion Criteria7

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
Group 2 - Pediatric participants
Parent/legal guardian unwilling or unable to provide consent
Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Interventions

DEVICEInvestigational contact OCT system

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.

DEVICEInvestigational noncontact OCT system:

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.