Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 5:24 PM
Study NCT ID:
NCT01616108
Status:
UNKNOWN
Last Update Posted:
2019-09-23
First Post:
2012-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bupivacaine Injection of Eye Muscles to Treat Strabismus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D004948', 'term': 'Esotropia'}, {'id': 'D005099', 'term': 'Exotropia'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D001763', 'term': 'Blepharoptosis'}, {'id': 'D004172', 'term': 'Diplopia'}], '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': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2012-06-07', 'studyFirstSubmitQcDate': '2012-06-08', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eye alignment', 'timeFrame': '6 months after injection', 'description': 'Alignment of the two eyes as measured by prism cover test or other applicable test'}], 'secondaryOutcomes': [{'measure': 'Percentage correction of the pre-treatment eye deviation', 'timeFrame': '6 months after injection treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['strabismus', 'diplopia'], 'conditions': ['Strabismus', 'Esotropia', 'Exotropia', 'Graves Disease', 'Ptosis, Eyelid']}, 'referencesModule': {'references': [{'pmid': '23916485', 'type': 'BACKGROUND', 'citation': 'Miller JM, Scott AB, Danh KK, Strasser D, Sane M. Bupivacaine injection remodels extraocular muscles and corrects comitant strabismus. Ophthalmology. 2013 Dec;120(12):2733-2740. doi: 10.1016/j.ophtha.2013.06.003. Epub 2013 Aug 2.'}, {'pmid': '19393509', 'type': 'BACKGROUND', 'citation': 'Scott AB, Miller JM, Shieh KR. Bupivacaine injection of the lateral rectus muscle to treat esotropia. J AAPOS. 2009 Apr;13(2):119-22. doi: 10.1016/j.jaapos.2008.10.016.'}, {'pmid': '17135337', 'type': 'BACKGROUND', 'citation': 'Scott AB, Alexander DE, Miller JM. Bupivacaine injection of eye muscles to treat strabismus. Br J Ophthalmol. 2007 Feb;91(2):146-8. doi: 10.1136/bjo.2006.110619. Epub 2006 Nov 29.'}, {'pmid': '27079589', 'type': 'BACKGROUND', 'citation': 'Debert I, Miller JM, Danh KK, Scott AB. Pharmacologic injection treatment of comitant strabismus. J AAPOS. 2016 Apr;20(2):106-111.e2. doi: 10.1016/j.jaapos.2015.11.011.'}, {'pmid': '20126486', 'type': 'RESULT', 'citation': 'Scott AB, Miller JM, Shieh KR. Treating strabismus by injecting the agonist muscle with bupivacaine and the antagonist with botulinum toxin. Trans Am Ophthalmol Soc. 2009 Dec;107:104-9.'}], 'seeAlsoLinks': [{'url': 'http://www.srfsf.org', 'label': 'Homepage for The Strabismus Research Foundation.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to determine if bupivacaine injection of eye muscles can make them stronger and stiffer, and thereby correct the position of eyes that are turned in or mis-aligned, a condition generally termed strabismus. It seeks further to find out the different effects of various concentrations or formulations of bupivacaine, and whether addition of Botox to other eye muscles can add to the effect of bupivacaine and enhance the correction of strabismus.', 'detailedDescription': 'Patients eligible for inclusion in the study will be age 8 to 95 years and have an eye deviation (strabismus) that is potentially subject to surgical correction.\n\nThe eye alignment will be measured. The eye muscles may be measured by MRI. The eye will be anesthetized by eye drops. One or more eye muscles will be injected with bupivacaine. Botox® will be injected into the antagonist muscle in some cases to increase the effect of the bupivacaine.\n\nData on the strabismus deviation, any side effects of the drug injection, and the eye muscles as measured by MRI, will be recorded at intervals after injection. These data will be compared with the like measurements taken before injection.\n\nThe primary outcome will be the eye alignment change at 180 days. A secondary outcome will be the change in muscle size, strength, or stiffness.\n\nFor large strabismus deviations not fully corrected by a first injection, a second injection can be made. Follow-up alignment and muscle measurements will be as for the initial injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical pattern of strabismus of 5 prism diopters or more\n\nExclusion Criteria:\n\n* Active eye infection'}, 'identificationModule': {'nctId': 'NCT01616108', 'briefTitle': 'Bupivacaine Injection of Eye Muscles to Treat Strabismus', 'organization': {'class': 'OTHER', 'fullName': 'Smith-Kettlewell Eye Research Institute'}, 'officialTitle': 'Bupivacaine Injection of Eye Muscles to Treat Strabismus', 'orgStudyIdInfo': {'id': 'BPX-STRAB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine Injection', 'description': 'Differences in concentration from 0.75% to 3.0% are compared. Differences in volume for 1.0 mL to 3.0 mL are compared. Differences in compounding with addition of epinephrine will be used and compared to plain bupivacaine.', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Differences in concentration from 0.75% to 3.0% are compared. Differences in volume for 1.0 mL to 3.0 mL are compared. Differences in compounding with addition of epinephrine will be used and compared to plain bupivacaine.', 'armGroupLabels': ['Bupivacaine Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'ALAN B SCOTT, MD', 'role': 'CONTACT', 'email': 'abs@srfsf.org', 'phone': '415-509-2122'}, {'name': 'ALAN B SCOTT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Strabismus Research Foundation', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Alan B Scott, MD', 'role': 'CONTACT', 'email': 'abs@srfsf.org', 'phone': '415 923 3120'}, {'name': 'Joel M Miller, PhD', 'role': 'CONTACT', 'email': 'jmm@eidactics.com', 'phone': '415 672 0473'}], 'overallOfficials': [{'name': 'Alan B Scott, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strabismus Research Foundation'}, {'name': 'Joel M Miller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strabismus Research Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Smith-Kettlewell Eye Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eidactics', 'class': 'OTHER'}, {'name': 'Sutter Health', 'class': 'OTHER'}, {'name': 'Strabismus Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Alan B. Scott', 'investigatorAffiliation': 'Smith-Kettlewell Eye Research Institute'}}}}