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Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Duke University · with University of Pennsylvania, National Eye Institute (NEI) · NCT04995341

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
236
US sites recruiting
1
Study start
August 16, 2021
Record last updated
May 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Investigational ultracompact OCT and OCTA system; retinal photographs

Conditions: Retinopathy of Prematurity

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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)
  • Infant inborn or outborn at (SA 2 only):
  • 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
  • Duke Hospital (Years 1, 2 and 3) at high risk to require treatment for ROP irrespective of birth weight and gestational age (e.g. pre-plus, severe ROP in zone 1, APROP, etc.)
  • 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)
  • Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only)

Exclusion Criteria

  • 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)

Recruiting US locations

  • Duke University Eye Center

    Durham, NC 27705

    Site contact: Cynthia A Toth, MD · 9196845631 · cynthia.toth@duke.edu

Study contacts (from the official record)

  • Cynthia A Toth, MD · 919-684-5631 · cynthia.toth@duke.edu
  • Michelle N McCall, MCAPM, BA · 919-684-0544 · michelle.mccall@duke.edu
All healthy volunteers studies in North Carolina →
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) (NCT04995341) | Bored Studies