NCT06177639 · Duke University
Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
(WiSLO)
What this study 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.
View original scientific 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.
Interventions
DEVICE
WiSLO
Imaging with the research WiSLO device in non-contact mode (4 images from each eye)
DEVICE
Volk Pictor Plus™
Imaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye)
Primary outcome measures
Presence of microanatomy as measured by WiSLO image reading
Time frame: Standard 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 reading
Time frame: Standard 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 imaging
Time frame: Standard 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 imaging
Time frame: Standard 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 imaging
Time frame: Standard 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 Scales
Time frame: Standard 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 Scales
Time frame: Standard 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 evaluation
Time frame: Standard 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 evaluation
Time frame: Standard 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 Scales
Time frame: Standard 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 Scales
Time frame: Standard of care clinic visit - day 1
Determining subjective operator comfort and satisfaction using Likert Scales (Likert scores 1-5)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Durham, North Carolina
Collaborators
National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2025 · Source of record for eligibility and locations