Status:

RECRUITING

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Lead Sponsor:

Duke University

Collaborating Sponsors:

National Eye Institute (NEI)

Conditions:

Eye Diseases

Eligibility:

All Genders

30+ years

Brief Summary

The goal of this observational study is to test the use of a novel Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging in pediatric and adult subjects...

Detailed Description

The Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO) Optimized for Pediatric and Neonatal Imaging study brings together a cross-disciplinary team of biomedical engineers and ophthalmologists t...

Eligibility Criteria

Inclusion

  • Adults (≥18 years) that may or may not have eye pathology
  • Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. NOTE: We will not enroll inpatient pre-term infants or neonates. The youngest age at enrollment will be 30 days adjusted age using the NICH NRN Web-based Adjusted Age Calculator.
  • Adults and infant/child with or without prior pupil dilation for clinical eye care visit
  • Adult participant is able and willing to consent to study participation
  • Parent/Legal Guardian is able and willing to consent to study participation for the minor
  • Pediatric participant \>12 years is able and willing to assent to study participation

Exclusion

  • Participant or Parent/Legal Guardian unwilling or unable to provide consent
  • Participant has a health or eye condition that would preclude eye examination or retinal imaging (e.g. evidence of inflammation or infection of ocular surface or eyelids, or corneal opacity or cataract)

Key Trial Info

Start Date :

October 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT06177639

Start Date

October 1 2025

End Date

August 1 2026

Last Update

October 8 2025

Active Locations (1)

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Duke University Eye Center

Durham, North Carolina, United States, 27710