Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-13 @ 12:21 PM
Study NCT ID:
NCT05558059
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2022-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Retinal Vasculature in Infant Eyes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012178', 'term': 'Retinopathy of Prematurity'}, {'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea', 'timeFrame': 'During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)', 'description': 'Measured by retinal OCTA imaging.'}], 'secondaryOutcomes': [{'measure': 'Change in vascular density of superficial vascular plexus at the fovea and perifovea', 'timeFrame': 'During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)', 'description': 'Measured by retinal OCTA imaging.'}, {'measure': 'Change in avascular zone size of superficial, intermediate and deep vascular plexus', 'timeFrame': 'During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)', 'description': 'Measured by retinal OCTA imaging.'}, {'measure': 'Change in network length of intermediate and deep vascular plexus', 'timeFrame': 'During hospitalization (at approximately 32-44 weeks post menstrual age, PMA)', 'description': 'Vascular density of superficial vascular plexus at the fovea and perifovea; Avascular zone size of superficial, intermediate and deep vascular plexus; Network morphology of intermediate and deep vascular plexus; Network length of intermediate and deep vascular plexus.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Retinopathy of Prematurity', 'Optical Coherence Tomography', 'Perifoveal vasculature', 'Vascular development', 'Macular edema', 'ROP', 'OCT', 'Prematurity', 'Optical Coherence Tomography Angiography', 'OCTA'], 'conditions': ['Retinopathy of Prematurity']}, 'descriptionModule': {'briefSummary': 'Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Preterm infants undergoing screening for retinopathy of prematurity', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian\n* Parent/Legal 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 less than 34 6/7 weeks postmenstrual age at first visit\n\nExclusion Criteria:\n\n* Participant or Parent/Legal Guardian unwilling or unable to provide consent\n* Infant 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)"}, 'identificationModule': {'nctId': 'NCT05558059', 'briefTitle': 'Imaging Retinal Vasculature in Infant Eyes', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Elucidating Perifoveal Vasculature Development in Infants', 'orgStudyIdInfo': {'id': 'Pro00111105'}, 'secondaryIdInfos': [{'id': '1R01EY03413401', 'type': 'OTHER_GRANT', 'domain': 'National Eye Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': '16 preterm infants undergoing ROP screening to optimize methods to acquire and process beside infant perifoveal vascular imaging and assess rigor and reproducibility.\n\nThe visits in the ICN (Intensive Care Nursery) will occur between 32 and 43 weeks post menstrual age at the time of ROP screening exams. Study visits will include, but are not limited to:\n\n* Ocular examination\n* OCT imaging of retinal microanatomy\n* OCTA imaging of retinal microvasculature\n* Medical and ocular history\n* Adverse event documentation', 'interventionNames': ['Device: Handheld Optical Coherence Tomography with OCT Angiography']}], 'interventions': [{'name': 'Handheld Optical Coherence Tomography with OCT Angiography', 'type': 'DEVICE', 'otherNames': ['Handheld OCT and OCTA'], 'description': 'OCT systems are in vivo optical imaging technology that allows non-contact imaging of early-stage ocular pathology. They create real-time, non-invasive images of ocular microstructure and have become standard-of-care instruments in ophthalmic imaging in clinics and operating rooms. In contrast to the visible light used in clinical eye examinations, because infrared light is not visible, the participant is not disturbed by the light. OCT imaging allows the capture of hundreds of B-scan (cross-sectional) images in seconds. These B-scans are analyzed for depth-resolved information and can also be stacked to create a volume and the stack may be summed up to create a retinal image.\n\nOCT angiography (OCTA) is an extension of the OCT systems, by taking images at the same location over time to extract retinal vascular flow information. It has been utilized to assess the ocular blood flow in many adult and pediatric patients.', 'armGroupLabels': ['Cohort 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Xi Chen, MD', 'role': 'CONTACT', 'email': 'xi2.chen@duke.edu', 'phone': '919-684-8434'}, {'name': 'Michelle N McCall, MCAPM, BA', 'role': 'CONTACT', 'email': 'michelle.mccall@duke.edu', 'phone': '(919) 684-0544'}, {'name': 'Xi Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cynthia A Toth, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sina Farsiu, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gui-Shuang Ying, PhD', 'role': 'CONTACT', 'email': 'gsying@pennmedicine.upenn.edu', 'phone': '215-615-1514'}, {'name': 'Gui-Shuang Ying, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Xi Chen, MD', 'role': 'CONTACT', 'email': 'xi2.chen@duke.edu', 'phone': '(919) 684-8434'}, {'name': 'Michelle N McCall', 'role': 'CONTACT', 'email': 'michelle.mccall@duke.edu', 'phone': '(919) 684-0544'}], 'overallOfficials': [{'name': 'Xi Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be made available after the completion of the study.', 'ipdSharing': 'YES', 'description': 'The Elucidating Perifoveal Vascular Development in Infants study data cannot be analyzed for publication until they are released by the study Principal Investigator upon final review and approval by the Data Safety and Monitoring Committee.\n\nData will be made available as follows:\n\n* A summary, de-identified data set available upon request through direct inquiries to the Study PI or Statistical Analysis Center a year after publication.\n* By the end of the funding period, de-identified SAS data sets and form images corresponding to all data collection forms, as well as key derived variables, will be put on file with a data repository.\n* Researchers may request limited access data sets.\n* The raw and analyzed imaging datasets will be made available after the completion of this study.\n\nApproved recipients will need to enter into a data sharing agreement. Costs for compilation and access to the datasets will be the responsibility of the recipients.', 'accessCriteria': 'Data requests must be submitted to the PI or the Statistical Analysis Center. Approved recipients will need to enter into a data sharing agreement.\n\nCosts for compilation and access to the datasets will be the responsibility of the recipients.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}