Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-19 @ 11:52 AM
Study NCT ID:
NCT03672435
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Strabismus Recovery With Proparacaine and Oculocardiac Reflex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D001919', 'term': 'Bradycardia'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012996', 'term': 'Solutions'}, {'id': 'C005717', 'term': 'proxymetacaine'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2013-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain (post op pain Likert scale)', 'timeFrame': 'hours (1-4) in recovery room', 'description': 'pain scale description / observation.. Pain is ranked by patient or nurse from 0 (no pain) to 9 (much pain)'}], 'secondaryOutcomes': [{'measure': 'nausea', 'timeFrame': 'hours (1-4) in recovery room', 'description': 'observed or described nausea (presence or absence of nausea / vomiting)'}, {'measure': 'heart rate', 'timeFrame': 'hours (1-4) while in recovery room', 'description': 'recovery room heart rate'}, {'measure': 'time to recovery', 'timeFrame': 'minutes (30-240) from entry recovery room to discharge', 'description': 'time in recovery room'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post operative recovery', 'oculocardiac reflex', 'extra ocular muscle', 'conjunctiva', 'numbing drop', 'heart rate'], 'conditions': ['Strabismus', 'Bradycardia', 'Nausea', 'Pain']}, 'referencesModule': {'availIpds': [{'url': 'http://www.abcd-vision.org/OCR/OCR%20proparacaine%20de-identified.pdf', 'type': 'Individual Participant Data Set', 'comment': 'deidentified OCR topical anesthetic recovery outcomes'}], 'references': [{'pmid': '31819352', 'type': 'BACKGROUND', 'citation': 'Arnold RW, Bond AN. Does Topical Proparacaine Improve Postoperative Comfort After Strabismus Surgery? Clin Ophthalmol. 2019 Nov 20;13:2279-2283. doi: 10.2147/OPTH.S230498. eCollection 2019.'}, {'pmid': '29733898', 'type': 'RESULT', 'citation': 'Arnold RW, Biggs RE, Beerle BJ. Intravenous dexmedetomidine augments the oculocardiac reflex. J AAPOS. 2018 Jun;22(3):211-213.e1. doi: 10.1016/j.jaapos.2018.01.016. Epub 2018 May 5.'}]}, 'descriptionModule': {'briefSummary': 'Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex influence post strabismus surgery recovery.', 'detailedDescription': 'In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age, type of surgery. Several post-operative recovery outcome variables were prospectively monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'strabismus surgery patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Strabismus surgery\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03672435', 'acronym': 'OCRprop', 'briefTitle': 'Strabismus Recovery With Proparacaine and Oculocardiac Reflex', 'organization': {'class': 'OTHER', 'fullName': 'Alaska Blind Child Discovery'}, 'officialTitle': 'Does Proparacaine Enhance Strabismus Recovery', 'orgStudyIdInfo': {'id': 'ABCD OCR proparacaine'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'proparacaine', 'description': 'Received topical proparacaine 0.5% with routine antibiotic-steroid ointment in operative eye(s) following strabismus surgery', 'interventionNames': ['Drug: Topical Solution']}, {'label': 'No proparacaine', 'description': 'Received no topical proparacaine 0.5% but did receive routine antibiotic-steroid ointment in the operative eye(s) following strabismus surgery'}], 'interventions': [{'name': 'Topical Solution', 'type': 'DRUG', 'otherNames': ['proparacaine'], 'description': 'proparacaine 0.5% eye drop', 'armGroupLabels': ['proparacaine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert W Arnold, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alaska Blind Child Discovery'}]}, 'ipdSharingStatementModule': {'url': 'http://www.abcd-vision.org/OCR/index.html', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'current- ongoing', 'ipdSharing': 'YES', 'description': 'Study Website access', 'accessCriteria': 'public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alaska Blind Child Discovery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}