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Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
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

• 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

Locations
United States
North Carolina
Duke University Eye Center
RECRUITING
Durham
Contact Information
Primary
Xi Chen, MD, PhD
xi2.chen@duke.edu
(919) 684-8434
Backup
Michelle N McCall, MCAPM, BA
michelle.mccall@duke.edu
(919) 684-0544
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2027-09
Participants
Target number of participants: 50
Treatments
Experimental: Group 1: Healthy adult volunteers
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20)
Experimental: Group 2: Adult patients in ophthalmology clinics
Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)
Experimental: Group 3: Pediatric patients in ophthalmology clinics
Minor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10)
Related Therapeutic Areas
Sponsors
Leads: Duke University
Collaborators: National Institutes of Health (NIH), National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov