[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649889":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":36,"centralContacts":40,"locations":49,"responsibleParty":87,"collaborators":89,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":35,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":128,"whyStopped":35,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Test bedside UWF-OCT versus bionocular indirect ophthalmoscopic exam to identify RW-ROP and TR-ROP","EXPERIMENTAL","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.",[13],"Device: Ultra-widefield Optical Coherence Tomography (UWF-OCT)",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13,18],"Device: Wide-field ophthalmic imaging system",{"label":20,"type":10,"description":21,"interventionNames":22},"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.",[13],[24,31],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","Ultra-widefield Optical Coherence Tomography (UWF-OCT)","Handheld retinal OCT imaging at the bedside or in clinic with an ultra-widefield handheld optical coherence tomography",[20,9,15],[30],"optical coherence tomography",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Wide-field ophthalmic imaging system","Handheld wide-field ophthalmic fundus imaging at the bedside or in clinic",[15],null,[37],{"name":38,"affiliation":5,"role":39},"Xi Chen, MD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":35,"email":44},"CONTACT","919-684-8434","xi2.chen@duke.edu",{"name":46,"role":42,"phone":47,"phoneExt":35,"email":48},"Michelle N McCall, MCAPM, BA","919-684-0544","michelle.mccall@duke.edu",[50,77],{"facility":51,"status":35,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Duke University Eye Center","Durham","North Carolina","27705","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-78.89862,35.99403,{"lat":61,"lon":60},[64,66,67,68,71,73,75],{"name":65,"role":42,"phone":43,"phoneExt":35,"email":44},"Xi Chen, MD, PhD",{"name":46,"role":42,"phone":47,"phoneExt":35,"email":48},{"name":65,"role":39,"phone":35,"phoneExt":35,"email":35},{"name":69,"role":70,"phone":35,"phoneExt":35,"email":35},"Cynthia A Toth, MD","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":35,"phoneExt":35,"email":35},"Sharon F Freedman, MD",{"name":74,"role":70,"phone":35,"phoneExt":35,"email":35},"Sasapin G Prakalapakorn, MD",{"name":76,"role":70,"phone":35,"phoneExt":35,"email":35},"Roarke Horstmeyer, PhD",{"facility":78,"status":35,"city":79,"state":80,"zip":81,"country":55,"countryCode":56,"cosmosGeoPoint":82,"geoPoint":86,"contacts":35},"University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics","Philadelphia","Pennsylvania","19104",{"type":58,"coordinates":83},[84,85],-75.16362,39.95238,{"lat":85,"lon":84},{"type":88,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[90,92],{"name":91,"class":6},"University of Pennsylvania",{"name":93,"class":94},"National Eye Institute (NEI)","NIH","100649889","analyzing-retinal-microanatomy-in-retinopathy-of-prematurity-to-improve-care-100649889",false,"NCT07738874","Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care","Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 3 (BabySTEPS3)","(BabySTEPS3)","Inclusion Criteria:\n\n* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent\u002FLegal guardian\n* Parent\u002FLegal Guardian is able and willing to consent to study participation for the infant\n* Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age \\\u003C 35 weeks postmenstrual age at first visit\n* Infants transferred to nursery for ROP treatment (some participants)\n\nExclusion Criteria:\n\n* Participant or Parent\u002FLegal Guardian unwilling or unable to provide consent\n* Adult participant or infant\u002Fchild 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)\n* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)","ALL","0 Days","9 Months",{"count":107,"type":108},175,"ESTIMATED","INTERVENTIONAL",[111],"NA","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.",[114],"Retinopathy of Prematurity (ROP)",[116,117,26,118,119,120,121,122,123,124,125,126,127],"Optical Coherence Tomography (OCT)","Retinopathy of Prematurity","Referral warranted ROP (RW-ROP)","Treatment requiring ROP (TR-ROP)","Premature birth","Eye Diseases","Retinal Diseases","Obstetric Labor, Premature","Obstetric Labor Complications","Pregnancy Complications","Infant, Premature, Diseases","Infant, Newborn, Diseases","NOT_YET_RECRUITING","2026-07-27",{"date":131,"type":132},"2026-07-31","ACTUAL",{"date":134,"type":108},"2026-07-01",{"date":136,"type":108},"2031-12-31",{"name":5,"class":6},2]