Health Trials

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

Qualifiers

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 design

Treatments tested in this trial

  • WiSLO
  • Volk Pictor Plus™

Treatment groups

42 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Eye Institute (NEI)

Collaborator

Source ClinicalTrials.gov