Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06139523

Optimize Pediatric OCT Imaging

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Retinal Disease Cranial Nerve Diseases Eye Diseases Glaucoma Nervous System Diseases Ocular Hypertension Optic Nerve Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Lejla Vajzovic, MD

SUB_INVESTIGATOR

Mays Dairi, MD

SUB_INVESTIGATOR

Michelle McCall

CONTACT

[email protected]

9196840544

Neeru Sarin

CONTACT

[email protected]

9196685641

Ramiro Maldonado, MD

SUB_INVESTIGATOR

Sasapin G Prakalapakorn, MD

SUB_INVESTIGATOR

Sharon F Freedman, MD

SUB_INVESTIGATOR

Shwetha Mangalesh, MD

SUB_INVESTIGATOR

About this study

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 plan to enroll 10 healthy adult volunteers and 20 pediatric patients in clinic or undergoing examination under anesthesia. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with our prior investigational imaging with the same system. There is a risk of corneal abrasion with the contact imaging system (Theia imaging), however, this system is used in the setting of other contact imaging systems (such as RetCam fundus photography).

Imaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

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.

Other names: Theia 1 widefield imaging system

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.

Other names: Ultracompact swept source OCT system

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

    Time frame: Single imaging session (day 1)

    Retinal thickness (microns) at the fovea and surrounding optic nerve.

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle N McCall, MCAPM, BA

CONTACT

[email protected]

(919) 684-0544

Xi Chen, MD

CONTACT

[email protected]

(919)684-8434

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.