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Optical Coherence Tomography

High-Speed Eye Scanning Technology for Retinopathy of Prematurity (BabySTEPS2 Trial)

N/A

Recruiting

Led By Cynthia A Toth, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

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

Must have

Infant inborn or outborn at Duke Hospital (Years 1, 2 and 3) with birth weight ≤1000 grams, and/or 20 0/7 to 28/ 6/7 (<29 weeks) gestational age

Infant inborn or outborn at Duke Regional Hospital (Years 4 and 5) that meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks)

Must not have

Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)

Adult participant or infant/child has a health or eye condition that precludes eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract) (SA2 only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4.75-year study visit

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new, high-speed eye scanning technology on premature babies to see if it can predict problems with vision or neurological development later in life.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive imaging techniques like OCT and photography, there are minimal expected side effects related directly to the interventions being tested.

Eligibility Criteria

Inclusion Criteria

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

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

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My baby qualifies for ROP screening based on birth weight or gestational age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4.75-year study visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4.75-year study visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.75-year study visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of ease of imaging (Cohort 3 only)

Measurement of stress of imaging (Cohort 3 only)

Microanatomy as measured by OCT reading

+7 more

Secondary study objectives

Neurodevelopmental parental questionnaires at 5-year study visit (Cohort 1 only)

Neurodevelopmental scores at 5-year study visit (Cohort 1 only)

Other study objectives

OCT grading from commercial OCT device

Reference standard score for ROP vascular severity (Cohort 3 only)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4: Adult and pediatric participants enrolled for imaging during system developmentExperimental Treatment1 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 cameraExperimental Treatment2 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 progressionExperimental Treatment1 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 infancyExperimental Treatment1 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

0 / 4Eligibility criteria met