Assessing retinal health in preterm infants with advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the use of high-speed optical coherence tomography (OCT) technology to identify retinal abnormalities in very preterm infants at risk for retinopathy of prematurity (ROP). By comparing this advanced imaging method to traditional bedside retinal photographs, the research aims to uncover critical indicators of ROP and potential future visual or neurological issues. The goal is to enhance early intervention strategies and improve long-term health outcomes for these vulnerable infants. The study will involve infants who have previously participated in a related study and will be followed up as they reach preschool age.

Why it matters

Who can join: the full rules

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)

Where it's running

• Duke University Eye Center
  Durham, North Carolina, United States Recruiting
• University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
  Philadelphia, Pennsylvania, United States Not yet recruiting

Study contacts

• Principal investigator: Cynthia A Toth, MD — Duke University Eye Center
• Study coordinator: Cynthia A Toth, MD
• Email: cynthia.toth@duke.edu
• Phone: 919-684-5631

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for infants with Retinopathy of Prematurity in Europe

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.