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Group 3 - Control participants for Retinal Dystrophy (SS-HH-OCT Trial)

Q: Which individuals meet the eligibility criteria to participate in this research investigation?

To be deemed eligible for inclusion in this investigation, individuals must have a diagnosis of retinal dystrophy and fall within the age range of 0 to 8 years. There is an anticipated need for a total of 80 participants in this study.

Q: Does this clinical trial include the enrollment of individuals aged 65 years and above?

This clinical trial welcomes participants within the age range of infancy up to 8 years old.

Q: Are researchers currently enrolling participants for this medical study?

As per the information available on clinicaltrials.gov, this particular clinical trial is not actively seeking participants at the moment. The study was initially posted on December 1st, 2023 and last updated on December 11th, 2023. However, it's worth mentioning that there are currently 11 other studies in progress that are actively enrolling patients.

N/A

Recruiting

Led By Ramiro Maldonado, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant's age is between 0 through 8 years (<9 years)

No evidence of retinal pathology (For Controls (Group 3))

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

SS-HH-OCT Trial Summary

This trial aims to use a new imaging system to study the development and degeneration of the light-sensitive cells in the eyes of children with inherited retinal diseases. Participants will undergo imaging during their regular eye

Who is the study for?

This trial is for neonates, infants, and children showing signs of early-onset inherited retinal dystrophies (EORDs). Participants will be included based on their need for clinically-indicated eye exams or procedures related to EORDs. Specific inclusion and exclusion criteria details are not provided.Check my eligibility

What is being tested?

The study is testing the effectiveness of a new high-resolution imaging system called SS-HH-OCT in diagnosing and monitoring retinal dystrophy in young patients. It's an observational study where images are taken during routine eye checks.See study design

What are the potential side effects?

Since this is an observational study involving imaging during standard care, there are no direct side effects from any medication or treatment intervention being tested.

SS-HH-OCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am under 9 years old.

Select...

My eyes do not have any retinal problems.

Select...

I have a genetic condition confirmed by specific gene changes.

SS-HH-OCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with abnormal microanatomy as measured by OCT reading

Thickness of the participants retina at the fovea and surrounding optic nerve as measured by OCT reading

SS-HH-OCT Trial Design

3Treatment groups

Active Control

Group I: Group 3 - Control participantsActive Control1 Intervention

10 participants with normal retinal anatomy undergoing anesthesia for strabismus surgery as part of their clinically-indicated care.

Group II: Group 2 - Non-progressive Inherited Retinal Dystrophy (IRD)Active Control1 Intervention

20 participants with non-progressive IRD (n=20), a subset of IRDs that are less frequently referred to Duke Clinics

Group III: Group 1 - Progressive Inherited retinal dystrophy (IRD)Active Control1 Intervention

50 participants with progressive IRD; the most common IRD seen at Duke Clinics.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,406 Total Patients Enrolled

Ramiro Maldonado, MDPrincipal InvestigatorDuke University Eye Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to participate in this research investigation?

"To be deemed eligible for inclusion in this investigation, individuals must have a diagnosis of retinal dystrophy and fall within the age range of 0 to 8 years. There is an anticipated need for a total of 80 participants in this study."

Answered by AI

Does this clinical trial include the enrollment of individuals aged 65 years and above?

"This clinical trial welcomes participants within the age range of infancy up to 8 years old."

Answered by AI

Are researchers currently enrolling participants for this medical study?

"As per the information available on clinicaltrials.gov, this particular clinical trial is not actively seeking participants at the moment. The study was initially posted on December 1st, 2023 and last updated on December 11th, 2023. However, it's worth mentioning that there are currently 11 other studies in progress that are actively enrolling patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "SS-HH-OCT as a Novel Diagnostic Modality for Early-Onset Retinal Dystrophies (EORDs)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06177977.

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