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Optimize Pediatric OCT Imaging

Duke University · NCT06139523

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
30
US sites recruiting
1
Study start
January 24, 2024
Record last updated
August 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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 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).

Being studied: Investigational contact OCT system; Investigational noncontact OCT system:

Conditions: Retinal Disease; Glaucoma; Optic Nerve Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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)

Recruiting US locations

  • Duke University Eye Center

    Durham, NC 27710

    Site contact: Michelle McCall · 919-684-0544 · mccal023@mc.duke.edu

Study contacts (from the official record)

  • Xi Chen, MD · (919)684-8434 · xi2.chen@duke.edu
  • Michelle N McCall, MCAPM, BA · (919) 684-0544 · michelle.mccall@duke.edu
All healthy volunteers studies in North Carolina →
Optimize Pediatric OCT Imaging (NCT06139523) | Bored Studies