Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care
ConditionRetinopathy of Prematurity (ROP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-9
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian
Parent/Legal Guardian is able and willing to consent to study participation for the infant
Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age < 35 weeks postmenstrual age at first visit
Infants transferred to nursery for ROP treatment (some participants)
Disqualifiers
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)
Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)
Trial design
Design model
Single group
Treatments tested in this trial
Ultra-widefield Optical Coherence Tomography (UWF-OCT)
DeviceHandheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography
Wide-field ophthalmic imaging system
DeviceHandheld wide-field ophthalmic fundus imaging at the bedside or in clinic
Treatment groups
175 Participants
are divided into 3 treatment groupsGroup A: Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROPExperimental treatment 1 intervention
Group B: Test bedside UWF-OCT versus fundus photos to identify RW-ROP and TR-ROPExperimental treatment 2 interventions
Group C: Test UWF-OCT versus binocular indirect ophthalmoscopic exam to characterize ROP regressionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of ultra-widefield OCT vs bionocular indirect ophthalmoscopy or fundus photograph to identify referral-warranted retinopathy of prematurity
OCT markers that determine the presence or absence of referral-warranted retinopathy of prematurity.
Time frame
Up to 60 weeks post-menstrual age2
Measurement of infant stress
Assessment of stress and discomfort using modified CRIES score (crying 0-4; facial expression 0-2; heart rate beats per minute; change in respiratory support) during each eye imaging and compared to baseline pre-imaging score adverse events recorded during imaging (bradycardia, tachycardia, desaturation, emesis, and ocular adverse events e.g. conjunctival hemorrhage)
Time frame
Up to 60 weeks post-menstrual ageSecondary outcomes
1
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading
Retinal thickness (microns) at the fovea and surrounding optic nerve.
Time frame
Up to 9 months corrected age2
Artificial Intelligence algorithms to classify ROP
Development of clinician-in-the-loop AI-based ROP classification algorithm for OCT imaging
Time frame
Up to 60 weeks post-menstrual age3
ROP vascular severity score
Scale of 1-9 based on retinal vessel dilation and tortuosity
Time frame
Up to 9 months corrected age4
ROP severity as determined by clinical exam
Clinical determination of the presence and/or severity of retinal vessel tortuosity, aggressive ROP, extra retinal neovascularization, shunt vessels, vitreous opacities, vitreous haze, retinoschisis and retinal detachment
Time frame
Up to 9 months corrected ageSponsors and contacts
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Duke University
Lead sponsor
University of Pennsylvania
Collaborator
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov