Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
This study, called BabySTEPS2, is looking at how a new handheld imaging system, called an investigational ultracompact OCT and OCTA system, compares to standard retinal photographs. This new system helps doctors see tiny details of the retina (the light-sensitive tissue at the back of the eye) in very premature babies. The goal is to find early signs of Retinopathy of Prematurity (ROP), a condition that can affect vision in premature infants. Researchers hope this new technology can better predict which babies might need ROP treatment or have vision or brain development problems later on. The study is currently unclear about its status and plans to include 236 participants. Success will be measured by visual acuity (how well someone sees), visual function, and neurodevelopmental scores in children at ages 2, 4.75, and 5 years old. Only children who were part of a previous study (BabySTEPS1) and whose parents agree can join.
- Study design
- This is an interventional study with a planned enrollment of 236 participants. It compares an investigational ultracompact OCT and OCTA system with retinal photographs.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Cohort 1 will have visual acuity measured at a 5-year study visit, visual function at a 4.75-year study visit, and neurodevelopmental scores at a 2-year study visit.
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Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
At a glance
Conditions
NCT04995341
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Duke University Eye Center
Durham, North Carolinastudy coordinator listed
Recruiting
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvaniastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Cynthia A Toth, MD · PRINCIPAL_INVESTIGATOR · Duke University Eye Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Optotype Visual acuity scores (Cohort 1 only)5-year study visit
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.
- Visual function scores (Cohort 1 only)4.75-year study visit
Visual function at the 4.75-year visit is measured by the presence or absence of strabismus, nystagmus, and amblyopia
- Neurodevelopmental scores at 2-year study visit (Cohort 1 only)2-year study visit
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.
- Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3)Up to 42 weeks post-menstrual age
Retinal thickness (microns) at the fovea and surrounding optic nerve.
- Microanatomy as measured by OCT readingUp to 42 weeks post-menstrual age
Combination of presence and severity of: retinal vessel tortuosity, vascular abnormality score by OCT (VASO), aggressive ROP, extra retinal neovascularization, vitreous abnormalities, shunt vessels, retinoschisis and retinal detachment.
- Microanatomy as measured by retinal photo reading (Cohort 3 only)Up 42 weeks post-menstrual age
Combination of presence and severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment.
- Microanatomy as measured by clinical exam (Cohort 1-3)Up to 42 weeks post-menstrual age
Clinical determination of combination presence and severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment.
- Measurement of stress of imaging (Cohort 3 only)Up to 42 weeks post-menstrual age
Assessment of stress and discomfort using modified CRIES score (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support) during each eye imaging and compared to baseline pre-imaging score adverse events recorded during imaging (bradycardia, tachycardia, desaturation, emesis, and ocular adverse events e.g. conjunctival hemorrhage)
- Assessment of ease of imaging (Cohort 3 only)Up to 42 weeks post-menstrual age
Based on Likert scales (1-5)
- ROP vascular severity score (Cohort 3 only)Up to 42 weeks post-menstrual age
Based on a combination of relative retinal vessel tortuosity score, extraretinal neovascularization and aggressive ROP.