Handheld widefield scanning laser retinal camera for newborns, children, and adults
Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
This test will use a handheld widefield infrared retinal camera (WiSLO) in infants, children, and adults to see if it's more comfortable for patients and operators and if its images match those from a standard handheld fundus camera.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 42 (estimated) |
| Ages | 30 Days and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06177639 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll up to 42 participants at Duke Eye Center, including infants (≥30 days adjusted age), children, and adult patients or healthy adult volunteers. Each participant will have noncontact imaging of both eyes with the research WiSLO device and with a commercial handheld color fundus camera (Volk Pictor Plus), and experience will be recorded using age-appropriate Likert scales or CRIES for infants. The study compares patient and operator comfort/satisfaction and whether WiSLO near-infrared images provide image quality comparable to color fundus camera images across ages and different fundus pigmentation. Initial clinical data will inform further technical refinement and larger clinical validation toward a portable, scalable pediatric retinal imaging tool.
Who should consider this trial
Good fit: Ideal candidates are infants (≥30 days adjusted age), children, and adults who are undergoing clinical eye evaluation or healthy adult volunteers and who can provide consent (or whose parent/guardian can consent).
Not a fit: Patients unlikely to benefit or who are excluded include inpatient preterm neonates and those with ocular surface disease, corneal opacity, active eye infection, or other conditions that prevent safe retinal imaging, and anyone unwilling or unable to consent.
Why it matters
Potential benefit: If successful, WiSLO could make retinal imaging easier and more comfortable for infants and children and expand access to pediatric retinal care with a portable, scalable device.
How similar studies have performed: Handheld fundus cameras and some handheld SLO devices have been used successfully, but this specific WiSLO design for widefield pediatric and neonatal imaging is novel and has limited clinical data so far.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Durham, North Carolina
- Duke University Eye Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia A Toth, MD — Duke University Eye Center
- Study coordinator: Cynthia A Toth, MD
- Email: cynthia.toth@duke.edu
- Phone: (919) 684-9170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.