Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
ConditionRetinopathy of Prematurity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDuke University
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only
Parent/Legal Guardian is able and willing to consent to study participation with follow up approximately between 4.5 and 5 years of age (consent available in Spanish* and English) (SA 1 only)
Parent/Legal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only)
Infant/child undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only)
Disqualifiers
Participant or Parent/Legal Guardian unwilling or unable to provide consent
Adult participant or infant/child has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract) (SA2 only)
Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)
Trial design
Design model
Single group
Treatments tested in this trial
Investigational ultracompact OCT and OCTA system
DeviceHandheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece
retinal photographs
Deviceretinal photographs with a commercial portable bedside widefield fundus camera system
Treatment groups
236 Participants
are divided into 4 treatment groupsGroup A: Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancyExperimental treatment 1 intervention
Group B: Cohort 2: Test of bedside OCT imaging data to predict RW-ROP or ROP progressionExperimental treatment 1 intervention
Group C: Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal cameraExperimental treatment 2 interventions
Group D: Cohort 4: Adult and pediatric participants enrolled for imaging during system developmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Optotype Visual acuity scores (Cohort 1 only)
HOTV visual acuity at the 5-year study visit. Visual acuity is recorded as the last line of the HOTV chart on which over 50% of the 4 symbols are identified correctly identified by the participant. If the participant is not capable of performing HOTV, then Teller cards will be used for preferential-looking visual acuity assessment. With Teller, acuity is determined by the smallest cycles per degree.
Time frame
5-year study visit2
Visual function scores (Cohort 1 only)
Visual function at the 4.75-year visit is measured by the presence or absence of strabismus, nystagmus, and amblyopia
Time frame
4.75-year study visit3
Neurodevelopmental scores at 2-year study visit (Cohort 1 only)
Neurodevelopmental testing at the 2-year neurodevelopment study visit: a) Bayley Scales of Infant and Toddler Development: Scores motor skills with the standardized mean motor score of 100; less than 85 indicates mild impairment; less than 70 indicates moderate to severe impairment.
Time frame
2-year study visit4
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3)
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Time frame
Up to 42 weeks post-menstrual ageSecondary outcomes
1
Neurodevelopmental scores at 5-year study visit (Cohort 1 only)
Wechsler Preschool and Primary Scale of Intelligence - 4: Measures specific aspects of working memory. Each subtest produces scaled scores from 1 to 19, with average scores between 7 and 12.
Time frame
5-year study visit2
Neurodevelopmental scores at 5-year study visit (Cohort 1 only)
Movement Assessment Battery for Children: Comprehensive measurement of motor skills \& is a well-known standardized test for detecting movement difficulty in children. Higher scores reflect more motor impairment.
Time frame
5-year study visit3
Neurodevelopmental scores at 5-year study visit (Cohort 1 only)
Developmental Test of Visual Motor Integration: Non-verbal assessment that gauges the degree to which participants can integrate visual and motor abilities. Lower scores reflect more impairment.
Time frame
5-year study visit4
Neurodevelopmental parental questionnaires at 5-year study visit (Cohort 1 only)
Child Behavior Checklist: 113 questions scored on a 3-point Likert frequency scale; scores below 93rd% are considered normal, scores 93-97th% are borderline and score above 97th% is in clinical range.
Time frame
5-year study visitOther outcomes
1
Axial length as measured in millimeters (Cohort 1 only)
Time frame
4.75-year study visit2
OCT grading from commercial OCT device
Based on combination of presence or absence of retinal vessel dragging, retinal detachment and fundus pigmentation (blond, medium, dark) from ultra-widefield fundus imaging; and OCT imaging (nerve fiber layer and center foveal thickness).
Time frame
4.75-year study visit3
Reference standard score for ROP vascular severity (Cohort 3 only)
The reference standard is the consensus determination based on a combination of OCT and photographic imaging of the relative retinal vessel tortuosity score \& clinical ROP exam determination of plus, pre-plus, neither, and for all 3 assessments extraretinal neovascularization and aggressive ROP.
Time frame
Up to 42 weeks post-menstrual ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
University of Pennsylvania
Collaborator
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov