[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438903":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":42,"centralContacts":47,"locations":57,"responsibleParty":111,"collaborators":113,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":127,"sex":128,"minAge":51,"maxAge":51,"enrollmentInfo":129,"targetDuration":51,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":59,"whyStopped":51,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"Duke University","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancy","EXPERIMENTAL","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",[13],"Device: Investigational ultracompact OCT and OCTA system",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"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.",[13,22],"Device: retinal photographs",{"label":24,"type":10,"description":25,"interventionNames":26},"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.",[13],[28,36],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DEVICE","Investigational ultracompact OCT and OCTA system","Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece",[9,15,19,24],[34,35],"optical coherence tomography","optical coherence tomography angiography",{"type":29,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"retinal photographs","retinal photographs with a commercial portable bedside widefield fundus camera system",[19],[41],"RetCam",[43],{"name":44,"affiliation":45,"role":46},"Cynthia A Toth, MD","Duke University Eye Center","PRINCIPAL_INVESTIGATOR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","919-684-5631",null,"cynthia.toth@duke.edu",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Michelle N McCall, MCAPM, BA","919-684-0544","michelle.mccall@duke.edu",[58,95],{"facility":45,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Durham","North Carolina","27705","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-78.89862,35.99403,{"lat":69,"lon":68},[72,74,76,79,81,83,85,87,89,91,93],{"name":44,"role":49,"phone":73,"phoneExt":51,"email":52},"9196845631",{"name":54,"role":49,"phone":75,"phoneExt":51,"email":56},"9196840544",{"name":77,"role":78,"phone":51,"phoneExt":51,"email":51},"Sharon F Freedman, MD","SUB_INVESTIGATOR",{"name":80,"role":78,"phone":51,"phoneExt":51,"email":51},"Charles M Cotten, MD, MHS",{"name":82,"role":78,"phone":51,"phoneExt":51,"email":51},"Joseph A Izatt, PhD",{"name":84,"role":78,"phone":51,"phoneExt":51,"email":51},"Christian Viehland, PhD",{"name":86,"role":78,"phone":51,"phoneExt":51,"email":51},"Kathryn E Gustafson, MD",{"name":88,"role":78,"phone":51,"phoneExt":51,"email":51},"Lejla Vajzovic, MD",{"name":90,"role":78,"phone":51,"phoneExt":51,"email":51},"Susapin G Prakalapakorn, MD",{"name":92,"role":78,"phone":51,"phoneExt":51,"email":51},"Xi Chen, MD, PhD",{"name":94,"role":78,"phone":51,"phoneExt":51,"email":51},"Sara Grace, MD",{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":63,"countryCode":64,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19104",{"type":66,"coordinates":102},[103,104],-75.16362,39.95238,{"lat":104,"lon":103},[107],{"name":108,"role":49,"phone":109,"phoneExt":51,"email":110},"Gui-Shuang Ying, PhD","215-615-1514","gsying@pennmedicine.upenn.edu",{"type":112,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[114,116],{"name":115,"class":6},"University of Pennsylvania",{"name":117,"class":118},"National Eye Institute (NEI)","NIH","100438903","retinal-microanatomy-in-retinopathy-of-prematurity-babysteps2-100438903",false,"NCT04995341","Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)","Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)","BabySTEPS2","Inclusion Criteria:\n\n* Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only\n* Parent\u002FLegal 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)\n* Parent\u002FLegal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only)\n* Infant\u002Fchild undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only)\n* Infant inborn or outborn at (SA 2 only):\n* Duke Hospital (Years 1, 2 and 3) with birth weight ≤1000 grams, and\u002For 20 0\u002F7 to 28\u002F 6\u002F7 (\\\u003C29 weeks) gestational age\n* 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.)\n* 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)\n* Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only)\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) (SA2 only)\n* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)",true,"ALL",{"count":130,"type":131},236,"ESTIMATED","INTERVENTIONAL",[134],"NA","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.",[137],"Retinopathy of Prematurity",[139,140,137,141,142],"Optical Coherence Tomography (OCT)","Optical Coherence Tomography Angiography (OCTA)","Neurodevelopment","Visual Acuity","2026-05-19",{"date":145,"type":146},"2026-05-22","ACTUAL",{"date":148,"type":146},"2021-08-16",{"date":150,"type":131},"2027-03-31",{"name":5,"class":6},2]