High-Speed Eye Scanning Technology for Retinopathy of Prematurity

(BabySTEPS2 Trial)

Recruiting at 1 trial location

Overseen By Cynthia A Toth, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Consent refusal, Eye condition, Anencephaly, others

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

Compensation: Varies

Number of Visits: 2

236 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new high-speed eye scanning technology to detect and understand eye problems in very preterm infants, focusing on retinopathy of prematurity (ROP). The goal is to determine if this investigational ultracompact OCT and OCTA system surpasses traditional methods in identifying early signs of eye issues that could affect vision or brain development. The trial uses a special eye scanner at the bedside to capture detailed images that might predict the need for future treatments. It is suitable for infants born very early or with a birth weight under 1500 grams, especially those at high risk for eye issues, and includes some children and adults for comparison and development of the technology. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve early detection and treatment of eye issues in vulnerable infants.

Will I have to stop taking my current medications?

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

What prior data suggests that this high-speed eye scanning technology is safe for retinopathy of prematurity?

Research has shown that the new ultracompact OCT (optical coherence tomography) system is generally safe and well-tolerated. Studies have found that using OCT for eye imaging in premature babies causes less stress than traditional eye exams, resulting in reduced discomfort for the babies during the procedure.

The device has been used in both adults and children without any serious side effects, suggesting it is safe for all ages. However, as this technology is new, ongoing studies are crucial to confirm its safety and effectiveness in detecting and predicting retinopathy of prematurity (ROP).

Overall, current evidence supports the OCT system as a safe option for eye imaging, particularly for young and vulnerable patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses investigational ultracompact OCT and OCTA systems to improve the detection and management of retinopathy of prematurity (ROP). Unlike traditional methods, which often rely on indirect ophthalmoscopic exams or standard retinal cameras, this cutting-edge technology offers high-speed, non-invasive imaging that can be performed at the bedside. The OCT system’s detailed imaging capabilities could enhance the accuracy of ROP diagnosis and track its progression more effectively, reducing stress for the infants involved. This approach could significantly improve early detection and intervention strategies, potentially leading to better outcomes for at-risk infants.

What evidence suggests that this high-speed eye scanning technology is effective for retinopathy of prematurity?

Research has shown that high-speed optical coherence tomography (OCT), tested in this trial, can capture detailed images of the eye, aiding in the early detection of retinopathy of prematurity (ROP). Studies have found that OCT effectively identifies significant changes in the eyes of premature babies, which may indicate the potential severity of ROP. This technology provides clear images without stressing the babies, offering a significant advantage over older methods like retinal photographs. Early results from handheld OCT devices suggest they are promising tools for enhancing early diagnosis and treatment planning for ROP. The ability to see these tiny details could lead to better outcomes for babies at risk. ^{3 6 7 8 9}

Who Is on the Research Team?

Cynthia A Toth, MD

Principal Investigator

Duke University Eye Center

Are You a Good Fit for This Trial?

This trial is for very preterm infants with a high risk of developing retinopathy of prematurity (ROP), which can affect vision. It includes those born at Duke Hospital weighing ≤1000 grams or <29 weeks gestational age, and others meeting ROP screening criteria. Also eligible are children previously in BabySTEPS1 and adults who may have eye pathology.

Inclusion Criteria

My child is scheduled for an exam under anesthesia, which may include an eye check.

My newborn is at high risk for ROP and was born at Duke Hospital.

My baby was born at Duke Hospital, weighs ≤1000 grams, or was born before 29 weeks of pregnancy.

Exclusion Criteria

My infant has a serious brain development condition not related to being premature.

Participant or Parent/Legal Guardian unwilling or unable to provide consent

I cannot have an eye exam due to a condition like corneal opacity or cataract.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Data Collection

Participants undergo investigational bedside OCT imaging to gather data on retinal microanatomy and microvasculature.

Up to 42 weeks post-menstrual age

Multiple visits (in-person)

Follow-up

Participants are monitored for neurodevelopmental and visual outcomes, including testing at 2-year and 5-year study visits.

5 years

2-year and 5-year follow-up visits

Long-term Follow-up

Participants may continue to be monitored for long-term visual and neurodevelopmental outcomes.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Investigational ultracompact OCT and OCTA system
• retinal photographs

Trial Overview

The study tests an advanced optical coherence tomography (OCT) system against traditional color photographs to detect early signs of ROP in preterm infants. The goal is to predict the need for treatment and potential visual or neurological issues up to preschool age.

How Is the Trial Designed?

Group I: Cohort 4: Adult and pediatric participants enrolled for imaging during system development Experimental Treatment 1 Intervention

12 awake healthy adult controls and 6 pediatric participants undergoing examination under anesthesia in the operating room will be imaged with the investigational bedside OCT for the purpose of technological development.

Group II: Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal camera Experimental Treatment 2 Interventions

102 infants, who are a sub-group of the 132 enrolled in Cohort 2, will also have imaging with a conventional, commercially available, retinal camera system to compare utility, stress, and prediction and documentation of referral-warranted ROP between the camera images and those from investigational OCT.

Group III: Cohort 2: Test of bedside OCT imaging data to predict RW-ROP or ROP progression Experimental Treatment 1 Intervention

294 infants at risk for retinopathy of prematurity: 176 will be enrolled and have investigational bedside OCT retinal imaging, and their data will be combined with that from 118 infants who had similar imaging in BabySTEPS1 for analysis of the total group versus the indirect ophthalmoscopic clinical exam data.

Group IV: Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancy Experimental Treatment 1 Intervention

109 pediatric participants who were previously enrolled in BabySTEPS1 from July 22, 2016 - December 30, 2020 will be enrolled for follow-up neurodevelopmental testing, visual acuity, visual function testing and investigational retinal imaging

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

The newly designed handheld OCT probe operates at high speeds (200 kHz) and provides rapid, non-invasive imaging of the retina and choroid in young children and infants, significantly improving the efficiency of pediatric ophthalmic imaging sessions.

This system not only reduces total imaging time but also enhances image quality for OCT angiography, making it a valuable tool for clinicians working with young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a clinical prototype of a miniature hand-held optical coherence tomography probe for prematurity and pediatric ophthalmic imaging. Song, S., Zhou, K., Xu, JJ., et al.[2020]

A new handheld optical coherence tomography (OCT) and OCT angiography (OCTA) system has been developed, featuring a 400-kHz speed and a 55-degree field of view, which enhances the ability to capture high-quality images quickly, crucial for patients in sensitive positions like infants in the NICU.

This portable system has successfully imaged conditions such as retinopathy of prematurity in premature infants and other retinal diseases, indicating its potential to improve diagnosis and treatment in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-speed and widefield handheld swept-source OCT angiography with a VCSEL light source. Ni, S., Wei, X., Ng, R., et al.[2022]

Optical coherence tomography (OCT) provides high-resolution, noninvasive imaging of the retina, achieving a remarkable longitudinal resolution of 10 microns, which is better than other imaging techniques.

OCT is quick and patient-friendly, with scan acquisition taking only 2.5 seconds, making it an effective tool for diagnosing various retinal diseases such as macular holes and macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular disease and optical coherence tomography. Coker, JG., Duker, JS.[2019]

The handheld swept source OCT (SS-OCT) device successfully captured high-quality images of retinal structures in awake premature infants, demonstrating its feasibility for assessing conditions like retinopathy of prematurity (ROP) without sedation or direct ocular contact.

In a study involving 12 infants, the device provided valuable insights into vitreoretinal characteristics, including microvascular abnormalities, which could help predict the severity of ROP, highlighting its potential as a non-invasive diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handheld swept-source optical coherence tomography with angiography in awake premature neonates. Moshiri, Y., Legocki, AT., Zhou, K., et al.[2022]

Portable optical coherence tomography (OCT) technology has improved the diagnosis and management of retinopathy of prematurity (ROP) in infants, allowing for objective disease assessment and categorization without sedation.

Next-generation OCT imaging enables minimally-invasive monitoring of disease progression and provides detailed three-dimensional mapping of the retina, enhancing the ability to visualize both normal and abnormal blood vessel development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages of Widefield Optical Coherence Tomography in the Diagnosis of Retinopathy of Prematurity. Nguyen, TP., Ni, S., Khan, S., et al.[2022]

The newly developed handheld swept source optical coherence tomography (SS-OCT) device offers high-speed imaging at 350 kHz with 10 µm axial resolution, making it effective for capturing detailed retinal images in just 1.4 seconds.

This technology not only allows for early detection of retinal diseases but also expands the potential for use in various settings beyond traditional clinics, such as pediatrics and military medicine, enhancing accessibility to eye care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handheld ultrahigh speed swept source optical coherence tomography instrument using a MEMS scanning mirror. Lu, CD., Kraus, MF., Potsaid, B., et al.[2022]

In a study of 49 premature infants using handheld spectral-domain optical coherence tomography (SD-OCT), 93% showed persistence of inner retinal layers, indicating that these layers remain intact regardless of the severity of retinopathy of prematurity (ROP).

Cystoid macular edema (CME) was observed in 54% of the infants, but its occurrence did not correlate with the ROP stage, suggesting that other factors may contribute to CME in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subclinical macular findings in infants screened for retinopathy of prematurity with spectral-domain optical coherence tomography. Dubis, AM., Subramaniam, CD., Godara, P., et al.[2022]

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Our group has shown that OCT imaging is less stressful than eye examinations using indirect ophthalmoscopy in preterm infants undergoing ROP screening.10 ...