Auto-aligning handheld OCT for adult and pediatric retinal imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot observational imaging study of a new handheld OCT device that uses auto-alignment, online image-quality detection, and automatic saving to improve retinal image capture. The device will be used to acquire OCT and OCTA images in 20 healthy adult volunteers, 20 adult ophthalmology patients, and 10 pediatric patients seen at the Duke Eye Center. Imaging will occur in clinic settings or during clinically indicated examinations under anesthesia for pediatric patients when appropriate. The protocol builds on prior handheld OCT work and reports no known risks associated with the imaging procedure.

Why it matters

Who can join: the full rules

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 it's running

• Duke University Eye Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Xi Chen, MD, PhD — Duke University
• Study coordinator: Xi Chen, MD, PhD
• Email: xi2.chen@duke.edu
• Phone: (919) 684-8434

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.