Advancing Pediatric Retinal Imaging With Auto-aligned OCT

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06841575
Status
Recruiting

Conditions

  • Eye Diseases
  • Glaucoma
  • Optic Nerve Diseases
  • Retinal Disease

Eligibility Criteria

Sex
ALL
Age
1 Month - N/A
Healthy Volunteers
Accepted

Interventions

  • Auto-aligned OCT — DEVICE
    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

Study Details

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.

Key Dates

Start date
Mar 23, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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)

Primary Outcome Measure

Number of participants with abnormal retinal microanatomy [ Time Frame: Up to 4 single imaging sessions at clinical visits over 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Eye CenterDurhamNorth Carolina27710
Michelle N McCall, MCAPM, BA
919-684-0544
Neeru Sarin, MD
(919) 668-5641
Anthony Kuo, MD (SUB_INVESTIGATOR)
Hafeez Dhalla, PhD (SUB_INVESTIGATOR)

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