Actively Recruiting
Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
Led by Duke University · Updated on 2025-10-08
42
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older, with or without eye diseases
- Infants or children undergoing clinical eye evaluation, with or without eye diseases, excluding inpatient pre-term infants or neonates
- Pediatric participants must be at least 30 days adjusted age
- Adults and pediatric participants may have had prior pupil dilation for clinical care
- Adult participants able and willing to consent to participate
- Parent or legal guardian able and willing to consent for minors
- Pediatric participants older than 12 years able and willing to assent to participation
You will not qualify if you...
- Participant or parent/legal guardian unwilling or unable to provide consent
- Participant has a health or eye condition preventing eye examination or retinal imaging, such as inflammation, infection of ocular surface or eyelids, corneal opacity, or cataract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
C
Cynthia A Toth, MD
CONTACT
M
Michelle N McCall, MCAPM, BA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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