Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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

Locations
United States
North Carolina
Duke University Eye Center
RECRUITING
Durham
Contact Information
Primary
Xi Chen, MD
xi2.chen@duke.edu
(919)684-8434
Backup
Michelle N McCall, MCAPM, BA
michelle.mccall@duke.edu
(919) 684-0544
Time Frame
Start Date: 2024-01-24
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Group 1: Healthy adult volunteers
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10)
Pediatric participants
Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20)
Sponsors
Leads: Duke University

This content was sourced from clinicaltrials.gov

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