Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-20 @ 5:55 PM
Study NCT ID:
NCT05643456
Status:
COMPLETED
Last Update Posted:
2022-12-08
First Post:
2020-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005099', 'term': 'Exotropia'}], 'ancestors': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group will do two muscles surgery; bilateral lateral rectus recession. The 2nd group will do three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2020-12-26', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'alignment in the primary position', 'timeFrame': '1 week to 6 months', 'description': 'measuring any misalignment by prism bar'}, {'measure': 'palpebral fissure height', 'timeFrame': '1 week to 6 months', 'description': 'measuring with millimeter'}, {'measure': 'End gaze deficit', 'timeFrame': '1 week to 6 months', 'description': 'measuring with prism bar'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exotropia']}, 'descriptionModule': {'briefSummary': 'Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia', 'detailedDescription': 'Exotropia is classified as Primary which includes constant and intermittent exotropias. Secondary XT include Sensory and consecutive XT. Management for IXT consists of non-surgical and surgical treatment. There is some controversy regarding the optimal surgical method varying between bilateral lateral rectus recession (BLR), unilateral lateral rectus recession-medial rectus resection (RR) and bilateral medial rectus resection (BMR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type.\n\nExclusion Criteria:\n\n1. Angle of deviation less than 40 PD or more than 55 PD.\n2. History of previous surgery.\n3. Inconcomitant exotropia.\n4. Incomitance in any gaze.\n5. Associated vertical deviation(oblique dysfunction,A or V pattern).\n6. Patients with neurological deficit.'}, 'identificationModule': {'nctId': 'NCT05643456', 'acronym': 'XT', 'briefTitle': 'Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison Between The Results Of Operating Two Muscles And Operating Three Muscles For The Treatment Of Large Angle Exotropia', 'orgStudyIdInfo': {'id': 'RIO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group 1 :Two muscle surgery', 'description': '30 patients will underwent two muscle surgery(bilateral lateral rectus muscle recession)', 'interventionNames': ['Procedure: surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group 2:Three muscle surgery', 'description': '39 patients underwent three muscle surgery(bilateral lateral rectus muscle recession with unilateral medial rectus muscle tucking)', 'interventionNames': ['Procedure: surgery']}], 'interventions': [{'name': 'surgery', 'type': 'PROCEDURE', 'description': '69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group 30 patients had two muscles surgery; bilateral lateral rectus recession.\n\nThe 2nd group 39 patients had three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.', 'armGroupLabels': ['group 1 :Two muscle surgery', 'group 2:Three muscle surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0000', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Reham fawzy elsherbiny', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Lobna MH Khazbm, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant lecturer', 'investigatorFullName': 'reham fawzy elsherbiny', 'investigatorAffiliation': 'Cairo University'}}}}