Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Duke University

Status: Not yet enrolling

Conditions: Optic Nerve Diseases; Glaucoma; Retinal Disease; Eye Diseases

Treatments: Device: Auto-aligned OCT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06841575

R21EY036545 (U.S. NIH Grant/Contract)

Pro00116369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1+ month old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Group 1: Healthy adult volunteers

Experimental group

Description:

Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20)

Treatment:

Device: Auto-aligned OCT

Group 2: Adult patients in ophthalmology clinics

Experimental group

Description:

Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)

Treatment:

Device: Auto-aligned OCT

Group 3: Pediatric patients in ophthalmology clinics

Experimental group

Description:

Minor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10)

Treatment:

Device: Auto-aligned OCT