Status:

RECRUITING

Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Lead Sponsor:

Duke University

Collaborating Sponsors:

National Institutes of Health (NIH)

National Eye Institute (NEI)

Conditions:

Eye Diseases

Retinal Disease

Eligibility:

All Genders

1+ years

Phase:

NA

Brief 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 pa...

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 c...

Eligibility 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
  • 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)

Key Trial Info

Start Date :

March 23 2026

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06841575

Start Date

March 23 2026

End Date

September 1 2027

Last Update

March 25 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

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Duke University Eye Center

Durham, North Carolina, United States, 27710

Advancing Pediatric Retinal Imaging With Auto-aligned OCT | DecenTrialz