RecruitingNot Applicable

Optimize Pediatric OCT Imaging

United States30 participantsStarted 2024-01-24

Plain-language summary

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Pregnancy Reasonably Excluded Guide (PREG) evaluation on women of childbearing potential * Group 2 - Pediatric participants * 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 - Pediatric participants * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of abnormal retinal microanatomy as measured by OCT reading

Timeframe: Single imaging session (day 1)

Severity of abnormal retinal microanatomy as measured by OCT reading

Timeframe: Single imaging session (day 1)

Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis

Timeframe: Single imaging session (day 1)

Trial details

NCT IDNCT06139523

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

Contact for this trial

Xi Chen, MD

(919)684-8434 xi2.chen@duke.edu

View on ClinicalTrials.gov More Retinal Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Presence of abnormal retinal microanatomy as measured by OCT reading

Timeframe: Single imaging session (day 1)

Severity of abnormal retinal microanatomy as measured by OCT reading

Timeframe: Single imaging session (day 1)

Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis

Timeframe: Single imaging session (day 1)