RECRUITING

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

Talk to us

Conditions

Retinal DystrophiesRetinal dystrophyInherited retinal dystrophyEarly onset retinal dystrophies (EORDS)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ultracompact Hand-Held Swept-Source Optical Coherence Tomography (SS-HH-OCT) as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)

Quick Facts

Study Start:2024-03-01
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06177977

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Years to 8 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participant's age is between 0 through 8 years (\<9 years)
  2. * Parent/legal guardian gives consents for the imaging study
  3. * No ocular media opacities that could preclude imaging
  4. * Refractive error equal or lower than 6 diopters
  5. * Autosomal dominant gene: One pathogenic or likely pathogenic variant that meets the clinical phenotype
  6. * Autosomal recessive gene: two pathogenic or likely pathogenic variants in-trans which meet the phenotype.
  7. * X-linked gene: one pathogenic or likely pathogenic variant which meets the phenotype.
  1. * Parent/legal guardian unwilling or unable to provide consent
  2. * Refractive error higher than 6.00 diopters
  3. * Participant has media opacities that preclude imaging
  4. * Any non-IRD ocular condition that confound results interpretation such as glaucoma, uveitis, neurologic conditions affecting the optic nerve, etc.

Contacts and Locations

Study Contact

Ramiro Maldonado, MD
CONTACT
(919) 684 5631
ramiro.maldonado@duke.edu
Michelle N McCall, MCAPM, BA
CONTACT
(919) 684-0544
michelle.mccall@duke.edu

Principal Investigator

Ramiro Maldonado, MD
PRINCIPAL_INVESTIGATOR
Duke University Eye Center

Study Locations (Sites)

Duke University Eye Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Retinal dystrophy
  • Inherited retinal dystrophy
  • Early onset retinal dystrophies (EORDS)

Additional Relevant MeSH Terms

  • Retinal Dystrophies