Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care

Conditions

• Retinopathy of Prematurity (ROP)

Eligibility Criteria

Sex

ALL

Age

0 Days - 9 Months

Healthy Volunteers

Not accepted

Interventions

• Ultra-widefield Optical Coherence Tomography (UWF-OCT) — DEVICE
  Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography
• Wide-field ophthalmic imaging system — DEVICE
  Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic

Study Details

Retinopathy of prematurity (ROP) is a disorder of development of the retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. A major barrier to improving ROP outcomes is the lack of easy access and low stress means to obtain objective measures of ROP disease severity across the retina in these infants. The long-term goal of this program is to provide information which will improve preterm infant health and vision via objective bedside imaging and analysis that characterizes retina-wide ROP level of disease, its response to treatment and development, and to rapidly translate this for better early intervention and improved future vision care.

Key Dates

First listed

Jul 31, 2026

Start date

Jul 1, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2031

Completion

Dec 31, 2031

Study Design

Enrollment

175 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP
  175 infants at risk for retinopathy of prematurity will be enrolled and have beside ultra-widefield OCT retinal imaging and standard-of-care binocular indirect ophthalmoscopic (BIO) exam.
• Experimental: Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROP
  455 infants at risk for retinopathy of prematurity: 175 infants will be enrolled and have beside ultra-widefield OCT retinal imaging, fundus imaging, and binocular indirect ophthalmoscopic exam. Data from newly enrolled infants will be combined with 280 infants who had similar imaging in BabySTEPS1, BabySTEPS2, and the Duke Investigational Pediatric OCT study to perform artificial intelligence (AI) based RW-ROP and TR-ROP severity assessment and to add OCT risk measures to AI-based prediction of RW-ROP and TR-ROP.
• Experimental: Test UWF-OCT versus binocular indirect ophthalmoscopic exam to characterize ROP regression
  45 infants treated for ROP: Compare OCT measures to clinical findings of ROP regression and identify early signs of ROP reactivation.

Primary Outcome Measure

Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurity [ Time Frame: Up to 60 weeks post-menstrual age ]

Central Contacts

• Xi Chen, MD
  919-684-8434
  [email protected]
• Michelle N McCall, MCAPM, BA
  919-684-0544
  [email protected]

Locations (2)

Find similar trials in Durham, NC

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