Comparing two OCT imaging systems for pediatric retina evaluation

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 observational pilot study aims to compare a new contact optical coherence tomography (OCT) system with an investigational noncontact OCT system to evaluate their effectiveness in imaging the pediatric retina. The study will enroll 10 healthy adult volunteers and 20 pediatric patients, assessing the contact system's ability to capture larger areas of the retina while maintaining similar image quality. Imaging data will be processed and analyzed at the Duke Advanced Research in SD/SSOCT Imaging Laboratory, with a focus on ensuring safety and minimizing risks associated with the imaging procedures.

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
* 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)

Where it's running

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

Study contacts

• Study coordinator: Xi Chen, MD
• 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.