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

Plain Language Summary

Simplified for easier understanding

This study is working to improve eye imaging technology called OCT (optical coherence tomography) specifically for use in children. OCT scans the back of the eye in fine detail, and this study aims to optimize how it is used in pediatric patients who may have difficulty staying still during the scan. **You may be eligible if...** - Group 1: You are a healthy adult volunteer over 18, with no known eye problems beyond needing glasses or contacts, and not pregnant - Group 2: You are a child under 18, your doctor has approved your participation, and your parent or guardian consents **You may NOT be eligible if...** - You are an adult with significant eye conditions beyond refractive error - You are a child whose parent or guardian does not consent - You are pregnant (for adult volunteers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.