Recruiting

Pediatric OCT

Sponsor:

Duke University

Code:

NCT06139523

Conditions

Retinal Disease

Glaucoma

Optic Nerve Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Investigational contact OCT system

Investigational noncontact OCT system:

Study Details

Brief 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).

Conditions

Retinal Disease

Glaucoma

Optic Nerve Diseases

Study ID

NCT06139523

Start date

Jan 24, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Pediatric participants

Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20)

Interventions

Investigational 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.

Investigational 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.

Primary outcome measure

  • Presence of abnormal retinal microanatomy as measured by OCT reading [ Time Frame: Single imaging session (day 1) ]
  • Severity of abnormal retinal microanatomy as measured by OCT reading [ Time Frame: Single imaging session (day 1) ]
  • Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis [ Time Frame: Single imaging session (day 1) ]

Central Contacts and Locations

Central contacts

Xi Chen, MD

(919)684-8434xi2.chen@duke.edu

Michelle N McCall, MCAPM, BA

(919) 684-0544michelle.mccall@duke.edu

Locations

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michelle McCall

919-684-0544mccal023@mc.duke.edu

Neeru Sarin

9196685641neeru.sarin@duke.edu

More Information

Sponsor

Duke University

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Optical Coherence Tomography (OCT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-05.