Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-03-25 @ 3:56 PM
Study NCT ID:
NCT02131792
Status:
COMPLETED
Last Update Posted:
2014-05-06
First Post:
2014-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-04', 'studyFirstSubmitDate': '2014-05-04', 'studyFirstSubmitQcDate': '2014-05-04', 'lastUpdatePostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.', 'timeFrame': 'preop, 6months postop', 'description': 'Measurement of deviation angle after slanted recession surgery was performed.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline of near-distance difference after slanted recession surgery at 6 months', 'timeFrame': 'preop, 6 months postop', 'description': 'Measurement of stereopsis after slanted recession was performed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intermittent Exotropia']}, 'descriptionModule': {'briefSummary': 'This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness', 'detailedDescription': 'This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more\n* Patients with follow up duration greater than 6 months\n\nExclusion Criteria:\n\n* Patients with previous ocular or strabismus surgery\n* Patients with ocular or neurologic pathologic conditions\n* Follow up duration less than 6 months'}, 'identificationModule': {'nctId': 'NCT02131792', 'briefTitle': 'Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness; A Prospective Study', 'orgStudyIdInfo': {'id': 'KNUH2014-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lateral Rectus Muscle Slanted Recession', 'description': 'Slanted recession of the lateral rectus muscle for the intermittent exotropia with convergence weakness', 'interventionNames': ['Procedure: Slanted recession of the lateral rectus muscle']}], 'interventions': [{'name': 'Slanted recession of the lateral rectus muscle', 'type': 'PROCEDURE', 'description': 'All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.', 'armGroupLabels': ['Lateral Rectus Muscle Slanted Recession']}]}, 'contactsLocationsModule': {'locations': [{'zip': '700-721', 'city': 'Daegu', 'state': 'Kyungsangpookdo', 'country': 'South Korea', 'facility': 'Bo Young Chun', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Bo Young Chun, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Ophthalmology, School of medicine, Kyungpook National University', 'investigatorFullName': 'Bo Young Chun', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}