SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06177977
Status
Recruiting
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Conditions

  • Retinal Dystrophies

Eligibility Criteria

Sex
ALL
Age
0 Years - 8 Years
Healthy Volunteers
Accepted

Interventions

  • SS-HH-OCT — DEVICE
    The investigational swept source OCT systems with handheld UC handpieces used in this study were developed at Duke University. OCT systems are non-contact, in-vivo optical imaging technology. The OCT system creates real-time, non-invasive images of ocular microstructure. OCT devices held above or in front of the eye while the sweeping infrared OCT beam scans across the retina. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sectional) images in seconds. These B-scans are then stacked to create a volume; the stack may be summed up to create a retinal image. These retinal images are similar to images acquired during retinal photography except that they were captured with infrared light and provide depth information. Each volume and B-scan image can be viewed individually to measure and analyze ocular pathology.

Study Details

The goal of this observational study is to utilize a novel imaging system designed for high-resolution retinal imaging of neonates, infants and children to identify the signs of photoreceptor development and degeneration in children with early-onset inherited retinal dystrophies (EORDs). Participants will have research imaging with SS-HH-OCT at the time of clinically-indicated eye examinations or procedures. The investigators aim to establish the basis for utilization of OCT imaging in earlier diagnosis and disease monitoring in children with EORDs. This work will set data reference standards and IRD endpoints that can be used in clinical trials.

Key Dates

Start date
Mar 1, 2024
Status verified
Oct 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Active Comparator: Group 1 - Progressive Inherited retinal dystrophy (IRD)
    100 participants with progressive IRD; the most common IRD seen at Duke Clinics.
  • Active Comparator: Group 2 - Non-progressive Inherited Retinal Dystrophy (IRD)
    20 participants with non-progressive IRD (n=20), a subset of IRDs that are less frequently referred to Duke Clinics
  • Active Comparator: Group 3 - Control participants
    50 participants with normal retinal anatomy undergoing anesthesia for strabismus surgery as part of their clinically-indicated care.

Primary Outcome Measure

Number of participants with abnormal microanatomy as measured by OCT reading [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Eye CenterDurhamNorth Carolina27710
Michelle McCall
[email protected]
919-684-0544
Neeru Sarin
[email protected]
9196685641
Ramiro Maldonado, MD (PRINCIPAL_INVESTIGATOR)
Cynthia A Toth, MD (SUB_INVESTIGATOR)
Mays Dairi, MD (SUB_INVESTIGATOR)

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By research site
Duke University Eye Center· Durham, NC

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