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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.75-year study visit
Awards & highlights
BabySTEPS2 Trial 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.Check my eligibility
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.See study design
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.
BabySTEPS2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born at Duke Hospital, weighs ≤1000 grams, or was born before 29 weeks of pregnancy.
Select...
My baby qualifies for ROP screening based on birth weight or gestational age.
BabySTEPS2 Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of ease of imaging (Cohort 3 only)
Measurement of stress of imaging (Cohort 3 only)
Microanatomy as measured by OCT reading
+7 moreSecondary outcome measures
Neurodevelopmental parental questionnaires at 5-year study visit (Cohort 1 only)
Neurodevelopmental scores at 5-year study visit (Cohort 1 only)
Other outcome measures
Axial length as measured in millimeters (Cohort 1 only)
OCT grading from commercial OCT device
Reference standard score for ROP vascular severity (Cohort 3 only)
BabySTEPS2 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
Find a Location
Who is running the clinical trial?
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,692 Total Patients Enrolled
15 Trials studying Retinopathy of Prematurity
4,422 Patients Enrolled for Retinopathy of Prematurity
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,833 Total Patients Enrolled
3 Trials studying Retinopathy of Prematurity
476 Patients Enrolled for Retinopathy of Prematurity
University of PennsylvaniaOTHER
2,000 Previous Clinical Trials
42,879,852 Total Patients Enrolled
4 Trials studying Retinopathy of Prematurity
5,441 Patients Enrolled for Retinopathy of Prematurity
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My infant has a serious brain development condition not related to being premature.I am over 18 years old and may or may not have eye problems.I cannot have an eye exam due to a condition like corneal opacity or cataract.My child was in BabySTEPS1 and agreed to be contacted for follow-up studies.My child's guardian can consent to a study lasting up to 5 years.My baby qualifies for ROP screening based on birth weight or gestational age.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal camera
- Group 2: Cohort 4: Adult and pediatric participants enrolled for imaging during system development
- Group 3: Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancy
- Group 4: Cohort 2: Test of bedside OCT imaging data to predict RW-ROP or ROP progression
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to become a participant in the trial?
"This clinical trial is actively recruiting, as evidenced by the information on clinicaltrials.gov. It was initially published on August 16th 2021 and revised most recently on February 15th 2022."
Answered by AI
How many participants are presently taking part in this research endeavor?
"Affirmative. Clinicaltrials.gov states that this research project is presently open for recruitment, having been initially posted on August 16th 2021 and last modified on February 15 2022. This clinical trial requires 236 participants from two seperate sites."
Answered by AI
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