Optimize Pediatric OCT Imaging

NCT06139523 | Recruiting FDA Device

• 1 other identifier: Pro00113627
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Optical Coherence Tomography (OCT)

Outcome Measures

Primary Outcomes (3)

• Presence of abnormal retinal microanatomy as measured by OCT reading

  Single imaging session (day 1)

• Severity of abnormal retinal microanatomy as measured by OCT reading

  Single imaging session (day 1)

• Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis

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

  Single imaging session (day 1)

Study Arms (2)

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)

Device: Investigational contact OCT system; Device: Investigational noncontact OCT system:

Pediatric participants

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

Device: Investigational contact OCT system; Device: Investigational noncontact OCT system:

Interventions

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.

Also known as: Theia 1 widefield imaging system

Group 1: Healthy adult volunteers; Pediatric participants

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.

Also known as: Ultracompact swept source OCT system

Group 1: Healthy adult volunteers; Pediatric participants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (9)

• Scott AW, Farsiu S, Enyedi LB, Wallace DK, Toth CA. Imaging the infant retina with a hand-held spectral-domain optical coherence tomography device. Am J Ophthalmol. 2009 Feb;147(2):364-373.e2. doi: 10.1016/j.ajo.2008.08.010. Epub 2008 Oct 9.

  PMID: 18848317 BACKGROUND

• Chavala SH, Farsiu S, Maldonado R, Wallace DK, Freedman SF, Toth CA. Insights into advanced retinopathy of prematurity using handheld spectral domain optical coherence tomography imaging. Ophthalmology. 2009 Dec;116(12):2448-56. doi: 10.1016/j.ophtha.2009.06.003. Epub 2009 Sep 18.

  PMID: 19766317 BACKGROUND

• Maldonado RS, Izatt JA, Sarin N, Wallace DK, Freedman S, Cotten CM, Toth CA. Optimizing hand-held spectral domain optical coherence tomography imaging for neonates, infants, and children. Invest Ophthalmol Vis Sci. 2010 May;51(5):2678-85. doi: 10.1167/iovs.09-4403. Epub 2010 Jan 13.

  PMID: 20071674 BACKGROUND

• Maldonado RS, Freedman SF, Cotten CM, Ferranti JM, Toth CA. Reversible retinal edema in an infant with neonatal hemochromatosis and liver failure. J AAPOS. 2011 Feb;15(1):91-3. doi: 10.1016/j.jaapos.2010.11.016.

  PMID: 21397814 BACKGROUND

• Maldonado RS, O'Connell R, Ascher SB, Sarin N, Freedman SF, Wallace DK, Chiu SJ, Farsiu S, Cotten M, Toth CA. Spectral-domain optical coherence tomographic assessment of severity of cystoid macular edema in retinopathy of prematurity. Arch Ophthalmol. 2012 May;130(5):569-78. doi: 10.1001/archopthalmol.2011.1846.

  PMID: 22232366 BACKGROUND

• Chen X, Mangalesh S, Dandridge A, Tran-Viet D, Wallace DK, Freedman SF, Toth CA. Spectral-Domain OCT Findings of Retinal Vascular-Avascular Junction in Infants with Retinopathy of Prematurity. Ophthalmol Retina. 2018 Sep;2(9):963-971. doi: 10.1016/j.oret.2018.02.001. Epub 2018 Mar 21.

  PMID: 30506013 BACKGROUND

• Chen X, Prakalapakorn SG, Freedman SF, Vajzovic L, Toth CA. Differentiating Retinal Detachment and Retinoschisis Using Handheld Optical Coherence Tomography in Stage 4 Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jan 1;138(1):81-85. doi: 10.1001/jamaophthalmol.2019.4796.

  PMID: 31774474 BACKGROUND

• Mangalesh S, Bleicher ID, Chen X, Viehland C, LaRocca F, Izatt JA, Freedman SF, Hartnett ME, Toth CA. Three-dimensional pattern of extraretinal neovascular development in retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2019 Apr;257(4):677-688. doi: 10.1007/s00417-019-04274-6. Epub 2019 Feb 21.

  PMID: 30790072 BACKGROUND

• Mangalesh S, Sarin N, McGeehan B, Prakalapakorn SG, Tran-Viet D, Cotten CM, Freedman SF, Maguire MG, Toth CA; BabySTEPS Group. Preterm Infant Stress During Handheld Optical Coherence Tomography vs Binocular Indirect Ophthalmoscopy Examination for Retinopathy of Prematurity. JAMA Ophthalmol. 2021 May 1;139(5):567-574. doi: 10.1001/jamaophthalmol.2021.0377.

  PMID: 33792625 BACKGROUND

MeSH Terms

Conditions

Retinal Diseases; Glaucoma; Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Eye Diseases; Ocular Hypertension; Cranial Nerve Diseases; Nervous System Diseases

Central Study Contacts

Xi Chen, MD

CONTACT

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

Michelle N McCall, MCAPM, BA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)