Widefield Confocal Scanning Laser Ophthalmoscope Optimized for Pediatric and Neonatal Imaging
ConditionEye Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
WiSLO
DeviceImaging with the research WiSLO device in non-contact mode (4 images from each eye)
Volk Pictor Plus™
DeviceImaging with the commercial handheld fundus camera, Volk Pictor Plus™ (4 images from each eye)
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Adult (≥18 years) cohort2 interventions
Group B: Minor cohort2 interventions
Trial outcomes
Primary outcomes
1
Presence of microanatomy as measured by WiSLO image reading
Presence (Yes/No) of retinal anatomy as measured from WiSLO and commercial OCT grading
Time frame
Standard of care clinic visit - day 12
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.
Time frame
Standard of care clinic visit - day 13
Presence of microanatomy from retinal photo imaging
Presence (Yes/No) of retinal microanatomy from commercially available fundus imaging (Volk Pictor Plus™) and WiSLO images.
Time frame
Standard of care clinic visit - day 14
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.
Time frame
Standard of care clinic visit - day 1Sponsors and contacts
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Duke University
Lead sponsor
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov