Clinical trial NCT06841575: Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Official title: Advancing Pediatric Retinal Imaging With Auto-aligned OCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eye Diseases
Retinal Disease
Glaucoma
Optic Nerve Diseases
Keywords: Optical Coherence Tomography (OCT)
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
First posted: 2025-02-24
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

Detailed description: Handheld OCT imaging is an advancement in ophthalmic imaging technology allowing us to image the pediatric retina. lt has tremendous potential to be applied to assess the structure and blood flow of children with retinal vascular diseases or as a screening tool for pediatric retinal diseases. Despite progress in the development of hand-held OCT probes, there remains a critical gap in technology to achieve fast, proper alignment between the imaging device and the infant eye. Even with the most skilled operators, to acquire consistent OCT and OCTA data capture for longitudinal follow up in uncooperative patients at the bedside remains difficult. lmprovements in hand-held OCT probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time, would address this critical gap in handheld OCT technology. Our biomedical engineering team, has developed prior iterations of the handheld OCT devices and successfully imaged the pediatric retina. The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.

The investigators plan to enroll 20 healthy adult volunteers, 20 adult patients and 10 pediatric patients from the ophthalmology clinic. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with prior iterations of handheld OCT devices. lmaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SS/SDOCT lmaging (DARSI) laboratory.

Eligibility criteria: Inclusion Criteria:

* Group 1: Healthy adult volunteers
* Subject is able and willing to consent to study participation
* Subject is more than 18 years of age
* Healthy adult volunteers without known ocular issues other than refractive error
* Group 2: Adult patients in ophthalmology clinics
* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject
* Subject is able and willing to consent to study participation
* Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics
* Group 3: Pediatric participants in ophthalmology clinics
* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
* Parent/legal guardian is able and willing to consent to study participation
* Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center

Exclusion Criteria:

* Group 1: Healthy adult volunteers
* Students or employees under direct supervision of the investigators
* Subjects with prior problems with pupil dilation
* Pregnant woman if receiving dilating drops
* Group 2: Adult patients in ophthalmology clinics
* Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
* Group 3: Pediatric participants in ophthalmology clinics
* Parent/legal guardian unwilling or unable to provide consent
* Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)

Primary outcomes:
measure: Number of participants with abnormal retinal microanatomy
timeFrame: Up to 4 single imaging sessions at clinical visits over 2 years
measure: Severity of abnormal retinal microanatomy
timeFrame: Up to 4 single imaging sessions at clinical visits over 2 years
measure: Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis
timeFrame: Up to 4 single imaging sessions at clinical visits over 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Xi Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: