Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Conditions

• Retinopathy of Prematurity

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Accepted

Interventions

• Investigational ultracompact OCT and OCTA system — DEVICE
  Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece
• retinal photographs — DEVICE
  retinal photographs with a commercial portable bedside widefield fundus camera system

Study Details

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.

Key Dates

Start date

Aug 16, 2021

Status verified

May 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

236 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancy
  109 pediatric participants who were previously enrolled in BabySTEPS1 from July 22, 2016 - December 30, 2020 will be enrolled for follow-up neurodevelopmental testing, visual acuity, visual function testing and investigational retinal imaging
• Experimental: Cohort 2: Test of bedside OCT imaging data to predict RW-ROP or ROP progression
  294 infants at risk for retinopathy of prematurity: 176 will be enrolled and have investigational bedside OCT retinal imaging, and their data will be combined with that from 118 infants who had similar imaging in BabySTEPS1 for analysis of the total group versus the indirect ophthalmoscopic clinical exam data.
• Experimental: Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal camera
  102 infants, who are a sub-group of the 132 enrolled in Cohort 2, will also have imaging with a conventional, commercially available, retinal camera system to compare utility, stress, and prediction and documentation of referral-warranted ROP between the camera images and those from investigational OCT.
• Experimental: Cohort 4: Adult and pediatric participants enrolled for imaging during system development
  12 awake healthy adult controls and 6 pediatric participants undergoing examination under anesthesia in the operating room will be imaged with the investigational bedside OCT for the purpose of technological development.

Primary Outcome Measure

Optotype Visual acuity scores (Cohort 1 only) [ Time Frame: 5-year study visit ]

Central Contacts

• Cynthia A Toth, MD
  919-684-5631
  [email protected]
• Michelle N McCall, MCAPM, BA
  919-684-0544
  [email protected]

Locations (2)

Find similar trials in Durham, NC

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