Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06177639
Status
Recruiting
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Conditions

  • Eye Diseases

Eligibility Criteria

Sex
ALL
Age
30 Days - N/A
Healthy Volunteers
Accepted

Interventions

  • WiSLO — DEVICE
    Imaging with the research WiSLO device in non-contact mode (4 images from each eye)
  • Volk Pictor Plus™ — DEVICE
    Imaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye)

Study Details

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 Dates

Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
42 participants (estimated)

Arms

  • Arm: Adult (≥18 years) cohort
    Adults that may or may not have eye pathology
  • Arm: Minor cohort
    Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. 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.

Primary Outcome Measure

Presence of microanatomy as measured by WiSLO image reading [ Time Frame: Standard of care clinic visit - day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Eye CenterDurhamNorth Carolina27710
Michelle McCall
[email protected]
919-684-0544
Neeru Sarin
[email protected]
9196685641
Cynthia A Toth, MD (PRINCIPAL_INVESTIGATOR)
Hafeez Dhalla, PhD (SUB_INVESTIGATOR)

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By research site
Duke University Eye Center· Durham, NC

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