RECRUITING

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Quick Facts

Study Start:2025-08-15
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06177639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults (≥18 years) that may or may not have eye pathology
  2. * 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.
  3. * Adults and infant/child with or without prior pupil dilation for clinical eye care visit
  4. * Adult participant is able and willing to consent to study participation
  5. * Parent/Legal Guardian is able and willing to consent to study participation for the minor
  6. * Pediatric participant \>12 years is able and willing to assent to study participation
  1. * Participant or Parent/Legal Guardian unwilling or unable to provide consent
  2. * 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)

Contacts and Locations

Study Contact

Cynthia A Toth, MD
CONTACT
(919) 684-9170
cynthia.toth@duke.edu
Michelle N McCall, MCAPM, BA
CONTACT
(919) 684-0544
michelle.mccall@duke.edu

Principal Investigator

Cynthia A Toth, MD
PRINCIPAL_INVESTIGATOR
Duke University Eye Center

Study Locations (Sites)

Duke University Eye Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Cynthia A Toth, MD, PRINCIPAL_INVESTIGATOR, Duke University Eye Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Eye Diseases