Advancing Pediatric Retinal Imaging With Auto-aligned OCT

March 23, 2026 updated by: Duke University
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Handheld OCT imaging is an advancement in ophthalmic imaging technology allowing us to image the pediatric retina. lt has tremendous potential to be applied to assess the structure and blood flow of children with retinal vascular diseases or as a screening tool for pediatric retinal diseases. Despite progress in the development of hand-held OCT probes, there remains a critical gap in technology to achieve fast, proper alignment between the imaging device and the infant eye. Even with the most skilled operators, to acquire consistent OCT and OCTA data capture for longitudinal follow up in uncooperative patients at the bedside remains difficult. lmprovements in hand-held OCT probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time, would address this critical gap in handheld OCT technology. Our biomedical engineering team, has developed prior iterations of the handheld OCT devices and successfully imaged the pediatric retina. The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

The investigators plan to enroll 20 healthy adult volunteers, 20 adult patients and 10 pediatric patients from the ophthalmology clinic. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with prior iterations of handheld OCT devices. lmaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SS/SDOCT lmaging (DARSI) laboratory.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Eye Center
        • Contact:
        • Sub-Investigator:
          • Hafeez Dhalla, PhD
        • Contact:
        • Sub-Investigator:
          • Anthony Kuo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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
  • Group 2: Adult patients in ophthalmology clinics
  • Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject
  • Subject is able and willing to consent to study participation
  • Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics
  • Group 3: Pediatric participants in ophthalmology clinics
  • 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: Adult patients in ophthalmology clinics
  • Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
  • Group 3: Pediatric participants in ophthalmology clinics
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Healthy adult volunteers
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20)
Device: Auto-aligned OCT
Swept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time
Experimental: Group 2: Adult patients in ophthalmology clinics
Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)
Device: Auto-aligned OCT
Swept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time
Experimental: Group 3: Pediatric patients in ophthalmology clinics
Minor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10)
Device: Auto-aligned OCT
Swept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with abnormal retinal microanatomy
Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) reading.
Up to 4 single imaging sessions at clinical visits over 2 years
Severity of abnormal retinal microanatomy
Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) reading.
Up to 4 single imaging sessions at clinical visits over 2 years
Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis
Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) analysis.
Up to 4 single imaging sessions at clinical visits over 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Eye Institute (NEI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Xi Chen, MD, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 19, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00116369
  • R21EY036545 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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