OCT Imaging for Retinopathy of Prematurity

Recruiting at 1 trial location

Overseen By Michelle N McCall

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Corneal opacity, Cataract, Anencephaly, others

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

Compensation: Varies

Number of Visits: 33

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how blood vessels form around the fovea, a crucial part of the retina, in infants. The research focuses on infants with retinopathy of prematurity, a condition that can lead to childhood blindness. Researchers use a special imaging device, Handheld Optical Coherence Tomography with OCT Angiography, to examine the eyes of preterm infants. Infants eligible for the trial are those undergoing retinopathy of prematurity screening and are less than 35 weeks postmenstrual age.

As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could improve early detection and treatment strategies for retinopathy of prematurity.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this handheld optical coherence tomography with OCT angiography is safe for infants?

Research has shown that using handheld Optical Coherence Tomography (OCT) with OCT Angiography (OCTA) is generally well-tolerated in infants. Studies have found that this imaging method is less stressful for preterm babies than traditional eye exams. This is important because it reduces the likelihood of causing discomfort or stress to the infants.

Previous studies on similar devices have found no significant harmful effects. Additionally, this technology does not touch the eye, reducing the risk of irritation or infection. These findings suggest that handheld OCT and OCTA are safe for imaging infants' eyes, including those with retinopathy of prematurity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Handheld Optical Coherence Tomography (OCT) with OCT Angiography for imaging retinal vasculature in infant eyes because it offers a non-invasive and portable way to capture detailed images of the eye's microanatomy and microvasculature. Unlike traditional methods that might require more cumbersome equipment or sedation, this handheld device can be used conveniently at the bedside, making it ideal for delicate preterm infants in intensive care. This technique aims to enhance the rigor and reproducibility of retinal imaging, potentially leading to better screening and management of conditions like Retinopathy of Prematurity (ROP).

What evidence suggests that this handheld optical coherence tomography with OCT angiography is effective for retinopathy of prematurity?

Studies have shown that a handheld device called Optical Coherence Tomography (OCT) with OCT Angiography effectively captures images of infants' eyes with retinopathy of prematurity (ROP). This trial will involve preterm infants undergoing ROP screening to optimize methods for acquiring and processing bedside infant perifoveal vascular imaging. Research indicates that handheld OCT causes less stress for infants compared to traditional eye exams. The device provides high-quality images that can identify the severity of ROP. This advancement could enhance the understanding and monitoring of this eye condition in premature infants. ^{1 2 3 4 6}

Who Is on the Research Team?

Xi Chen, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian

Parent/Legal Guardian is able and willing to consent to study participation for the infant

Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

ROP Screening and Imaging

Preterm infants undergo ROP screening and imaging to assess perifoveal vascular development

12 weeks

Multiple visits (in-person) between 32 and 44 weeks PMA

Follow-up

Participants are monitored for changes in vascular density and network morphology after initial imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Handheld Optical Coherence Tomography with OCT Angiography

How Is the Trial Designed?

Group I: Cohort 1 Experimental Treatment 1 Intervention

16 preterm infants undergoing ROP screening to optimize methods to acquire and process beside infant perifoveal vascular imaging and assess rigor and reproducibility. The visits in the ICN (Intensive Care Nursery) will occur between 32 and 43 weeks post menstrual age at the time of ROP screening exams. Study visits will include, but are not limited to: * Ocular examination * OCT imaging of retinal microanatomy * OCTA imaging of retinal microvasculature * Medical and ocular history * Adverse event documentation

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28750113/

Handheld Optical Coherence Tomography Angiography and ... Objective: To obtain ultra-wide-field OCT and OCTA images in neonates with ROP using a prototype handheld OCT and OCTA device. Design, setting, ...

2. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2778163

Preterm Infant Stress During Handheld Optical Coherence ... These findings suggest that investigational OCT imaging of ROP is less stressful than BIO examination by a trained ophthalmologist.

3. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2023.1191174/full

Vitreoretinal biomarkers of retinopathy of prematurity using ... This review discusses the known and novel biomarkers of ROP severity in premature infants identified through handheld OCT and potential for future directions.

4. qims.amegroups.org qims.amegroups.org/article/view/29627/html

Handheld swept-source optical coherence tomography with ... Background: Retinopathy of prematurity (ROP) can lead to retinal detachment and severe vision loss and is a common cause of childhood blindness. Optical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04995341

Study Details | NCT04995341 | Retinal Microanatomy in ... This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04995341

Retinal Microanatomy in Retinopathy of Prematurity ... This research builds on our group's ability to reliably capture and process non-contact, infrared optical coherence tomography (OCT) and OCT-angiography of ...