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

Study acronym: SS-HH-OCT
StatusCompleted
PhaseNot applicable
Started2024-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-09-30
Trial completed
Final enrollment: 137 participants (planned 80)
Primary completion confirmed: February 2026 (last estimated December 2026)
2025-10-02
2 amendments v5-v6
2 re-verifications since 2025-03-13, no change to tracked fields
2024-03-25
Study Status v4
Start dateestimated 2024-02→confirmed 2024-03-01
2024-02-09
Study Status v3
Start date2024-01→2024-02
2023-12-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2023-12→2024-01
Study sitesdetails revised at 1 of 1 site
2023-12-21
Study Status, Study Description, Outcome Measures v1
Primary endpoints2 entries, revised
MicroanatomyNumber of participants with abnormal microanatomy as measured by OCT reading RetinalThickness thicknessof the participants retina at the fovea and surrounding optic nerve as measured by OCT reading
Study description+30 characters
[...] wavelength, and an ergonomic light-weight handheld design. WeThe investigators hypothesize that imaging with this system will enable us to [...] hies (EORD)-associated PDCs in young children. To this end, wethe investigators propose the following specific aims: Specific Aim 1: Optimi [...]
2023-12-11
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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.
Trial Details
NCT Number NCT06177977
Lead Sponsor Duke University
Conditions Retinal Dystrophies
Enrollment 137 participants
Start Date 2024-03-01
Primary Completion 2026-02-05 (estimated)
Study Completion 2026-02-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-29