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Search / Trial NCT06177639

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Launched by DUKE UNIVERSITY · Dec 11, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new eye imaging tool called the Widefield Confocal Scanning Laser Ophthalmoscope (WiSLO), which is designed to be used for both children and adults. The main goal is to see if using this new device is more comfortable and satisfactory for patients and the healthcare providers compared to traditional imaging methods. The researchers also want to find out if the pictures taken with WiSLO are as clear and useful as those taken with standard color cameras, regardless of the patients' age or eye characteristics.

To participate in this study, adults aged 18 and older, as well as infants and children over 30 days old, can join if they are having an eye exam, whether they have eye issues or not. Participants will undergo imaging of their eyes using both the WiSLO and a regular hand-held camera. Parents or guardians will need to consent for minors, and older children will also need to agree to participate. It’s important to note that some health conditions may prevent participation, such as certain eye infections or problems. This trial is not yet recruiting participants, but it aims to gather important information about eye health and imaging techniques for people of all ages.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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)

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Cynthia A Toth, MD

Principal Investigator

Duke University Eye Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported