Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging

NCT06177639 | Recruiting FDA Device

• 2 other identifiers: Pro00111358R21EY033515
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Eye Diseases

Outcome Measures

Primary Outcomes (11)

• Presence of microanatomy as measured by WiSLO image reading

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

  Standard of care clinic visit - day 1

• Presence of abnormal microanatomy as measured by WiSLO image reading

  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.

  Standard of care clinic visit - day 1

• Presence of microanatomy from retinal photo imaging

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

  Standard of care clinic visit - day 1

• Severity of abnormal microanatomy from retinal photo imaging

  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.

  Standard of care clinic visit - day 1

• Time of image capture from WiSLO and commercially available fundus imaging

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

  Standard of care clinic visit - day 1

• Patient comfort as measured by Likert Scales

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

  Standard of care clinic visit - day 1

• Patient satisfaction as measured by Likert Scales

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

  Standard of care clinic visit - day 1

• Patient comfort as measured by CRIES evaluation

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

  Standard of care clinic visit - day 1

• Patient satisfaction as measured by CRIES evaluation

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

  Standard of care clinic visit - day 1

• Operator comfort as measured by Likert Scales

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

  Standard of care clinic visit - day 1

• Operator satisfaction as measured by Likert Scales

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

  Standard of care clinic visit - day 1

Study Arms (2)

Adult (≥18 years) cohort

Adults that may or may not have eye pathology

Device: WiSLO; Device: Volk Pictor Plus™

Minor cohort

Infant/child undergoing clinically-indicated examination that may or may not have eye pathology. 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.

Device: WiSLO; Device: Volk Pictor Plus™

Interventions

WiSLO DEVICE

Imaging with the research WiSLO device in non-contact mode (4 images from each eye)

Also known as: Widefield scanning laser ophthalmoscope

Adult (≥18 years) cohort; Minor cohort

Volk Pictor Plus™ DEVICE

Imaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye)

Adult (≥18 years) cohort; Minor cohort

Eligibility Criteria

• Age: 30 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for this research study may have eye conditions requiring clinical evaluation. Participants will be recruited from the patient population of Duke Eye Center. Healthy adult volunteers will be recruited from the patient population of Duke Eye Center, visitors attending clinical visits with Duke Eye Center patients, Duke Employees and Duke Students. No employees or students will be enrolled if under the direct supervision of the PI.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Duke University Eye Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Eye Diseases

Study Officials

• Cynthia A Toth, MD

  Duke University Eye Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia A Toth, MD

CONTACT

(919) 684-9170; cynthia.toth@duke.edu

Michelle N McCall, MCAPM, BA

CONTACT

(919) 684-0544; michelle.mccall@duke.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: October 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final research data will be available for at least the duration of the project.
• Access Criteria: We will archive final research data from the proposed project and make the underlying datasets available to other researchers upon request.

Locations

US (1)