Actively Recruiting

All Genders
Healthy Volunteers
NCT06139523

Optimize Pediatric OCT Imaging

Led by Duke University · Updated on 2025-09-17

30

Participants Needed

1

Research Sites

148 weeks

Total Duration

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AI-Summary

What this Trial 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).

CONDITIONS

Official Title

Optimize Pediatric OCT Imaging

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult volunteers more than 18 years of age
  • Adults able and willing to consent to study participation
  • Healthy adults without known eye issues other than refractive error
  • Pregnancy evaluation on women of childbearing potential
  • Pediatric patients younger than 18 years in Duke Eye Center clinics or undergoing clinically-indicated examination under anesthesia
  • Parent or legal guardian able and willing to consent for pediatric participants
  • Health care provider agrees that study personnel can contact the parent/legal guardian for pediatric patients
Not Eligible

You will not qualify if you...

  • Students or employees under direct supervision of the investigators
  • Adults with prior problems with pupil dilation
  • Pregnant women receiving dilating drops
  • Parent or legal guardian unwilling or unable to provide consent for pediatric participants
  • Pediatric participants with health or eye conditions preventing eye examination or retinal imaging, such as corneal opacity or cataract

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University Eye Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

X

Xi Chen, MD

CONTACT

M

Michelle N McCall, MCAPM, BA

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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