Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT04995341

Conditions

Retinopathy of Prematurity

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Investigational ultracompact OCT and OCTA system

retinal photographs

Study Details

Brief summary:

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.

Conditions

Retinopathy of Prematurity

Study ID

NCT04995341

Start date

Aug 16, 2021

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

236 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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.

Interventions

Investigational ultracompact OCT and OCTA system

Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece

retinal photographs

retinal photographs with a commercial portable bedside widefield fundus camera system

Primary outcome measure

  • Optotype Visual acuity scores (Cohort 1 only) [ Time Frame: 5-year study visit ]
  • Visual function scores (Cohort 1 only) [ Time Frame: 4.75-year study visit ]
  • Neurodevelopmental scores at 2-year study visit (Cohort 1 only) [ Time Frame: 2-year study visit ]
  • Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3) [ Time Frame: Up to 42 weeks post-menstrual age ]
  • Microanatomy as measured by OCT reading [ Time Frame: Up to 42 weeks post-menstrual age ]
  • Microanatomy as measured by retinal photo reading (Cohort 3 only) [ Time Frame: Up 42 weeks post-menstrual age ]
  • Microanatomy as measured by clinical exam (Cohort 1-3) [ Time Frame: Up to 42 weeks post-menstrual age ]
  • Measurement of stress of imaging (Cohort 3 only) [ Time Frame: Up to 42 weeks post-menstrual age ]
  • Assessment of ease of imaging (Cohort 3 only) [ Time Frame: Up to 42 weeks post-menstrual age ]
  • ROP vascular severity score (Cohort 3 only) [ Time Frame: Up to 42 weeks post-menstrual age ]

Central Contacts and Locations

Central contacts

Cynthia A Toth, MD

919-684-5631cynthia.toth@duke.edu

Michelle N McCall, MCAPM, BA

919-684-0544michelle.mccall@duke.edu

Locations

Duke University Eye Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Cynthia A Toth, MD

9196845631cynthia.toth@duke.edu

Michelle N McCall, MCAPM, BA

9196840544michelle.mccall@duke.edu

More Information

Sponsor

Duke University

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Optical Coherence Tomography (OCT)
  • Optical Coherence Tomography Angiography (OCTA)
  • Retinopathy of Prematurity
  • Neurodevelopment
  • Visual Acuity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-05-22.