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SS-HH-OCT for Early-Onset Retinal Dystrophies in Children

This study is testing a new imaging device called SS-HH-OCT (swept source OCT with handheld UC handpieces) to better understand early-onset retinal dystrophies (EORDs) in children. EORDs are inherited eye conditions that affect the retina (the light-sensitive tissue at the back of the eye). The SS-HH-OCT system creates detailed, real-time images of the eye's internal structures without touching the eye. Researchers want to see if this device can help identify signs of how photoreceptors (cells that detect light) develop and degenerate in children with EORDs. The goal is to improve early diagnosis and monitoring of these conditions. You might be able to join if you are between 0 and 8 years old, and for children with EORDs, if you have a clinical and molecular diagnosis of EORD. This study is currently recruiting 80 participants.

Study design
This is an interventional study planning to enroll 80 participants. It aims to optimize and use the SS-HH-OCT system to characterize retinal development and degeneration in children.
What's involved
Participants will have research imaging with the SS-HH-OCT device during their regular eye exams or procedures. The study will measure changes for up to 24 months.
Compensation
Not stated in the trial record.
Follow-up
Participants' retinal measurements will be taken for up to 24 months after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06177977

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

Recruiting
NAAges 0–8Interventional
Duke University
~80 participants
Updated 2025-10-06 on ClinicalTrials.gov
What's tested:SS-HH-OCT

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with abnormal microanatomy as measured by OCT reading
Measured over Up to 24 months
+1 more outcome measured

Conditions

Retinal Dystrophies

Explore related trials

Retinal DystrophyPathogenic variant

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Ramiro Maldonado, MD · PRINCIPAL_INVESTIGATOR · Duke University Eye Center

Who to contact

Ramiro Maldonado, MD
[email protected]
(919) 684 5631
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant's age is between 0 through 8 years (\<9 years)
Parent/legal guardian gives consents for the imaging study
No ocular media opacities that could preclude imaging
Refractive error equal or lower than 6 diopters
Autosomal dominant gene: One pathogenic or likely pathogenic variant that meets the clinical phenotype
Autosomal recessive gene: two pathogenic or likely pathogenic variants in-trans which meet the phenotype.
X-linked gene: one pathogenic or likely pathogenic variant which meets the phenotype.

Exclusion

Parent/legal guardian unwilling or unable to provide consent
Refractive error higher than 6.00 diopters
Participant has media opacities that preclude imaging
Any non-IRD ocular condition that confound results interpretation such as glaucoma, uveitis, neurologic conditions affecting the optic nerve, etc.

What this trial measures

  • Number of participants with abnormal microanatomy as measured by OCT readingUp to 24 months

    Presence of abnormal retinal microanatomy as measured by OCT reading

  • Thickness of the participants retina at the fovea and surrounding optic nerve as measured by OCT readingUp to 24 months

    Retinal thickness (microns) at the fovea and surrounding optic nerve