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Observational Study of WiSLO for Eye Imaging

This observational study is testing a new eye imaging device called WiSLO (Widefield Confocal Scanning Laser Ophthalmoscope) for children and adults. Researchers want to see if WiSLO is more comfortable and easier to use than current commercial devices like the Volk Pictor Plus™. They also want to compare the quality of images taken by WiSLO to those from standard color cameras. The study is looking for up to 42 participants, including adults and children (at least 30 days old) who may or may not have eye conditions. The main goal is to see if WiSLO can clearly show the tiny structures inside the eye. The current status of the study is unclear.

Study design
This is an observational study with a planned enrollment of 42 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have their eyes imaged with the research WiSLO device and the commercial Volk Pictor Plus™ (4 images from each eye) during a standard clinic visit.
Compensation
Not stated in the trial record.
Follow-up
Image readings will be taken at the standard of care clinic visit on day 1.

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NCT06177639

Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

Recruiting
Not specifiedAges 30+Observational
Duke University
~42 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:WiSLOVolk Pictor Plus™

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Presence of microanatomy as measured by WiSLO image reading
Measured over Standard of care clinic visit - day 1
+10 more outcomes measured

Conditions

Eye Diseases

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Eye Disorder

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

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

Who to contact

Cynthia A Toth, MD
[email protected]
(919) 684-9170
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Presence of microanatomy as measured by WiSLO image readingStandard of care clinic visit - day 1

    Presence (Yes/No) of retinal anatomy as measured from WiSLO and commercial OCT grading

  • Presence of abnormal microanatomy as measured by WiSLO image readingStandard of care clinic visit - day 1

    Combination of presence (Yes/No) and severity (e.g., mild, moderate, severe) of abnormal retinal structures as measured from WiSLO images and commercially available fundus images.

  • Presence of microanatomy from retinal photo imagingStandard of care clinic visit - day 1

    Presence (Yes/No) of retinal microanatomy from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.

  • Severity of abnormal microanatomy from retinal photo imagingStandard of care clinic visit - day 1

    Combination of presence (Yes/No) and severity (e.g., mild, moderate, severe) of abnormal retinal structures from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.

  • Time of image capture from WiSLO and commercially available fundus imagingStandard of care clinic visit - day 1

    Assessment of time of image capture from both WiSLO and commercially available fundus imaging.

  • Patient comfort as measured by Likert ScalesStandard of care clinic visit - day 1

    Determining subjective patient comfort and satisfaction using age appropriate Likert Scales for adults and minors (Likert scores 1 - 5)

  • Patient satisfaction as measured by Likert ScalesStandard of care clinic visit - day 1

    Determining subjective patient comfort and satisfaction using age appropriate Likert Scales for adults and minors (Likert scores 1 - 5)

  • Patient comfort as measured by CRIES evaluationStandard of care clinic visit - day 1

    Determining subjective patient comfort and satisfaction CRIES evaluation (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support).

  • Patient satisfaction as measured by CRIES evaluationStandard of care clinic visit - day 1

    Determining subjective patient comfort and satisfaction CRIES evaluation (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support).

  • Operator comfort as measured by Likert ScalesStandard of care clinic visit - day 1

    Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)

  • Operator satisfaction as measured by Likert ScalesStandard of care clinic visit - day 1

    Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)