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RECRUITING
NCT06177639

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Sponsor: Duke University

View on ClinicalTrials.gov

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 who are undergoing clinical evaluation for eye disease or are healthy adult volunteers. The main questions to answer are: * Whether WiSLO will be more comfortable and satisfactory in experience for the patient and operator than commercial alternatives. * If the quality of WiSLO near infrared images will be comparable to color fundus camera imaging across population of different ages and fundus pigmentation. Participants will have the following research procedures: * Imaging of both eyes with a research noncontact WiSLO * Imaging of both eyes with a commercially available non-contact hand held fundus camera (Volk Pictor Plus) * Likert scales for adults * Pediatric Likert scales for children * CRIES scales for infants.

Key Details

Gender

All

Age Range

30 Days - Any

Study Type

OBSERVATIONAL

Enrollment

42

Start Date

2025-10-01

Completion Date

2026-08

Last Updated

2025-10-08

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

WiSLO

Imaging with the research WiSLO device in non-contact mode (4 images from each eye)

DEVICE

Volk Pictor Plus™

Imaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye)

Locations (1)

Duke University Eye Center

Durham, North Carolina, United States