Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00279669
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2006-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012178', 'term': 'Retinopathy of Prematurity'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2010-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-27', 'studyFirstSubmitDate': '2006-01-17', 'studyFirstSubmitQcDate': '2006-01-17', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04-30', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Retinopathy of Prematurity', 'Ultrasound', 'Eye'], 'conditions': ['Retinopathy of Prematurity']}, 'referencesModule': {'references': [{'pmid': '15609519', 'type': 'RESULT', 'citation': 'Jokl DH, Silverman RH, Springer AD, Towers H, Kane S, Lopez R, Chiang MF, Lloyd HO, Barbazetto I, Horowitz R, Vidne O. Comparison of ultrasonic and ophthalmoscopic evaluation of retinopathy of prematurity. J Pediatr Ophthalmol Strabismus. 2004 Nov-Dec;41(6):345-50. doi: 10.3928/01913913-20041101-06.'}, {'pmid': '16491723', 'type': 'RESULT', 'citation': 'Jokl DH, Silverman RH, Nemerofiky SL, Kane SA, Chiang MF, Lopez R, Lee G. Is there a role for high-frequency ultrasonography in clinical staging of retinopathy of prematurity? J Pediatr Ophthalmol Strabismus. 2006 Jan-Feb;43(1):31-5. doi: 10.3928/01913913-20060101-04.'}, {'type': 'RESULT', 'citation': 'D. H. Kauffmann Jokl, R. H. Silverman, IV, S. Kane, R. Lopez, M. F. Chiang, and S. L. Nemerofsky. Cribside Ultrasonography for the Early Detection of Rapidly Progressive Zone 1 ROP Retinal Detachment: Implications for Early Surgical Intervention. Invest. Ophthalmol. Vis. Sci. 2007 48: E-Abstract 3094.'}]}, 'descriptionModule': {'briefSummary': 'Premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. This research study will use ultrasound to examine the eye for retinal changes of prematurity.', 'detailedDescription': "Retinopathy of prematurity requires the early detection of retinopathy in neonates with a gestational age of \\< 28 weeks and a birth weight \\<1500 g. These evaluations require pupillary dilation, diagnostic expertise, consume much time and expense and are not without morbidity.\n\nB-scan ultrasonography using a hand-held probe is part of the current ophthalmologist's armamentarium, providing a non-invasive view of the eye and avoiding the morbidity associated with mydriatic drops used for pupillary dilation.\n\nWe will use a simple water bath enclosure for a standard 20 MHz probe currently in general ophthalmic use to determine whether this simple technique might supplant indirect ophthalmoscopy as a screening technique. We will compare, using masked observers, the clinical findings of indirect ophthalmoscopy of neonatal infants with ultrasonic findings to determine if a correlation in the stages of retinopathy of prematurity (ROP) between the two techniques existed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature babies with Retinopathy of Prematurity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npremature birth\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT00279669', 'briefTitle': 'Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity', 'orgStudyIdInfo': {'id': 'ROP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound examination', 'type': 'PROCEDURE', 'otherNames': ['Quantel Cinescan'], 'description': 'contact ultrasound examination'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Presbyterian Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Dan H Kauffmann-Jokl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Ronald H Silverman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Columbia University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dan H. Kauffmann-Jokl, MD', 'oldOrganization': 'Columbia Presbyterian Medical Center'}}}}