RecruitingNot ApplicableNCT06841575

Advancing Pediatric Retinal Imaging With Auto-aligned OCT


Sponsor

Duke University

Enrollment

50 participants

Start Date

Mar 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 Month

Inclusion Criteria12

  • 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 Criteria9

  • 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)

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Interventions

DEVICEAuto-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


Locations(1)

Duke University Eye Center

Durham, North Carolina, United States

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NCT06841575


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