NCT06139523 · Duke University
Optimize Pediatric OCT Imaging
What this study is about
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 experimental noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina.
View original scientific description
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).
Interventions
DEVICE
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.
DEVICE
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 measures
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)
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Durham, North Carolina
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2025 · Source of record for eligibility and locations