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Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

NCT06177639 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2025-10-08

No results posted yet for this study

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.

Conditions

  • Eye Diseases

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)

Sponsors & Collaborators

Principal Investigators

  • Cynthia A Toth, MD · Duke University Eye Center

Eligibility

Min Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06177639 on ClinicalTrials.gov