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

Trial Summary

What is the purpose of this trial?

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.

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 data supports the effectiveness of the treatment using high-speed eye scanning technology for retinopathy of prematurity?

Research shows that high-speed optical coherence tomography (OCT) and OCT angiography (OCTA) are effective in diagnosing and monitoring retinopathy of prematurity (ROP) in infants. These technologies provide detailed images of the eye's structure and blood vessels without needing invasive procedures, making them useful for early detection and management of ROP. ^{1 2 3 4 5}

Is high-speed eye scanning technology safe for humans?

The high-speed eye scanning technology, including handheld optical coherence tomography (OCT) and OCT angiography (OCTA), is generally considered safe as it is non-invasive and has been successfully used in infants and young children without sedation. It allows for rapid and detailed imaging of the eye, reducing the need for more invasive procedures. ^{1 2 3 5 6}

How is the investigational ultracompact OCT and OCTA system treatment different from other treatments for retinopathy of prematurity?

This treatment uses a high-speed, handheld optical coherence tomography (OCT) and OCT angiography (OCTA) system, which allows for non-invasive, detailed imaging of the retina in infants, even in challenging settings like the neonatal intensive care unit. Its portability, speed, and wide field of view make it unique, enabling early detection and monitoring of retinal diseases without the need for sedation or invasive procedures. ^{1 3 4 5 7}

Research Team

Cynthia A Toth, MD

Principal Investigator

Duke University Eye Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

12 awake healthy adult controls and 12 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

250 infants at risk for retinopathy of prematurity: 132 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

80 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+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. China pubmed.ncbi.nlm.nih.gov

Handheld swept-source optical coherence tomography with angiography in awake premature neonates. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Subclinical macular findings in infants screened for retinopathy of prematurity with spectral-domain optical coherence tomography. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

High-speed and widefield handheld swept-source OCT angiography with a VCSEL light source. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Macular disease and optical coherence tomography. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Advantages of Widefield Optical Coherence Tomography in the Diagnosis of Retinopathy of Prematurity. [2022]

6. United States 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Handheld ultrahigh speed swept source optical coherence tomography instrument using a MEMS scanning mirror. [2022]