Recruiting NCT06841575

Advancing Pediatric Retinal Imaging With Auto-aligned OCT

No phase Interventional Eye Diseases Retinal Disease Glaucoma Optic Nerve Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Auto-aligned OCT.
Who it may be relevant to: Registry conditions: Eye Diseases, Retinal Disease, Glaucoma, Optic Nerve Diseases. Basic parameters: from 1 months · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

Device Auto-aligned OCT
Swept Source OCT system with improved hand-held 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

Primary outcome measures

Number of participants with abnormal retinal microanatomy [Time frame: Up to 4 single imaging sessions at clinical visits over 2 years]
Severity of abnormal retinal microanatomy [Time frame: Up to 4 single imaging sessions at clinical visits over 2 years]
Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis [Time frame: Up to 4 single imaging sessions at clinical visits over 2 years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Other

Study locations

United States · 1 center

Duke University Eye Center — Durham

Identifiers

NCT: NCT06841575 · Pro00116369 · R21EY036545

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗