NCT06841575 · Duke University
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
What this study is 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.
View original scientific description
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.
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
Measured by optical coherence tomography (OCT) reading.
Severity of abnormal retinal microanatomy
Time frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) reading.
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
Measured by optical coherence tomography (OCT) analysis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Durham, North Carolina
Collaborators
National Institutes of Health (NIH), National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2026 · Source of record for eligibility and locations