OCT Imaging Systems for Retinal Disease in Children

Overseen By Michelle N McCall, MCAPM, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Pregnancy, Corneal opacity, Cataract, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two types of eye imaging systems to determine which captures better images of the retina in children. One system uses direct contact with the eye, while the other does not. Researchers believe the contact system might cover larger areas of the eye, but both systems should provide similar image detail. Children with eye diseases receiving care at Duke Eye Center may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity for patients to contribute to advancements in pediatric eye care technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these OCT systems are safe for imaging the pediatric retina?

Research has shown that both the investigational contact and noncontact OCT (optical coherence tomography) systems are safe to use. Studies on OCT systems similar to the investigational contact OCT system indicate they are generally well-tolerated, with safety data comparable to other imaging methods. Patients did not experience significant issues during the procedures.

For the investigational noncontact OCT system, studies found this type of imaging to be safe and practical, with no major complications reported. This makes it a promising option.

Both systems aim to provide detailed images of the eye without causing harm to participants, suggesting these OCT systems are likely safe for imaging the pediatric retina in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on optimizing pediatric OCT (Optical Coherence Tomography) imaging, a non-invasive technique that provides high-resolution images of the eye's structures. Unlike traditional imaging methods, OCT offers detailed cross-sectional views without the need for injections or radiation, which is particularly beneficial for pediatric patients who may be more sensitive to such procedures. The trial aims to enhance this technology's precision and effectiveness specifically for children with eye diseases, potentially leading to earlier and more accurate diagnoses and better-tailored treatments for young patients.

What evidence suggests that these OCT systems are effective for imaging the pediatric retina?

This trial will compare the investigational contact OCT system with the investigational noncontact OCT system. Research has shown that both systems effectively capture images of the retina in children. The contact OCT system, which participants in this trial may receive, is expected to provide a wider view of the retina, aiding in the diagnosis and management of various eye diseases. Widefield OCT systems, like the contact OCT, may enhance understanding and treatment of retinal conditions in children. Meanwhile, the noncontact OCT system, another option in this trial, is promising because it causes less stress for young patients while still effectively assessing their eye health. Both systems aim to deliver high-quality images, essential for detecting and managing retinal issues in children. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

You are able and willing to agree to take part in the study.

Children are not eligible.

Your doctor or nurse, who knows about the study, gives permission for the study team to talk to your parent or legal guardian.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Session

Participants undergo a single imaging session using both contact and noncontact OCT systems to evaluate the pediatric retina

1 day

1 visit (in-person)

Data Analysis

Imaging data is processed, segmented, and analyzed in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory

2-4 weeks

Follow-up

Participants are monitored for any adverse events post-imaging

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational contact OCT system
• Investigational noncontact OCT system

How Is the Trial Designed?

Group I: Pediatric participants Experimental Treatment 2 Interventions

Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20)

Group II: Group 1: Healthy adult volunteers Experimental Treatment 2 Interventions

Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06139523

NCT06139523 | Optimize Pediatric OCT Imaging The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10138206/

Optical Coherence Tomography and ... - PubMed Central - NIH In this review, we discuss the use of OCTA and OCTA in various pediatric retinal diseases, including ROP, familial exudative vitreoretinopathy (FEVR), Coats ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.860371/full

Widefield Optical Coherence Tomography in Pediatric Retina The development of wider field OCT systems thus has the potential to improve the diagnosis and management of myriad diseases in both adult and ...

4. aao.org aao.org/disease-review/oct-in-ped-optic-neuropathies

Optical Coherence Tomography in Pediatric ... In the evaluation of optic neuropathies, OCT can provide valuable data about the microanatomy of the ONH, the RNFL, and the RGCs and other ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12123870/

Effectiveness of smartphone technology for detection of ... Smartphone applications are effective tools for detecting important causes of childhood eye disorders such as strabismus, retinopathy of prematurity, chalazion ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07092592

Optical Coherence Tomography (OCT) Based Intraoral ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN230043.pdf

Notal Vision Home Optical Coherence Tomography (OCT ... Data on the clinical performance of Notal Home OCT System was limited in the following populations: • Patients with vision worse than 20/80.

8. eurointervention.pcronline.com eurointervention.pcronline.com/article/a-multicentre-evaluation-of-the-safety-of-intracoronary-optical-coherence-tomography

A multicentre evaluation of the safety of intracoronary ... The incidence of complications encountered in relation to the OCT procedure is consistent with safety data from coronary angioscopy. Similarly, angioscopy ...

9. jscai.org jscai.org/article/S2772-9303(25)00018-3/fulltext

Efficacy and Safety of High-Frequency Optical Coherence ... In this multicenter, single-arm study, we evaluated the efficacy and safety of a novel imaging catheter and system called high-frequency optical coherence ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914907021248

Safety and Feasibility of an Intravascular Optical ... The aim of this study was to evaluate the safety and feasibility of intracoronary imaging with OCT in the clinical setting; 76 patients with ...