Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-28 @ 9:13 PM
Study NCT ID:
NCT05234957
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance
Sponsor:
Organization:
Raw JSON
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The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'undercorrection/recurrence', 'notes': 'postoperative deviation equal or greater than 10 prism diopter exotropia/phoria at distant and/or near fixation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'overcorrection', 'notes': 'postoperative deviation equal or greater than 10 prism diopter esotropia/phoria at distant and/or near fixation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ocular Alignment at Distant Fixation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '5.54', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.', 'unitOfMeasure': 'prism diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ocular Alignment at Near Fixation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '5.52', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '6.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.', 'unitOfMeasure': 'prism diopter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensory Status (Stereopsis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.'}], 'classes': [{'categories': [{'measurements': [{'value': '124', 'spread': '81.3', 'groupId': 'OG000'}, {'value': '119.5', 'spread': '54.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'one year', 'description': 'ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.', 'unitOfMeasure': 'second of arc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Stereopsis'}, {'type': 'SECONDARY', 'title': 'Sensory Status (Fusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.\n\nBilateral Lateral Rectus Recession: Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.'}, {'id': 'OG001', 'title': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.\n\nBilateral Lateral Rectus Recession: Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.'}], 'classes': [{'categories': [{'title': 'positive fusion', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'absent fusion', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'one year', 'description': 'Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.85', 'spread': '5.42', 'groupId': 'BG000'}, {'value': '8.75', 'spread': '5.48', 'groupId': 'BG001'}, {'value': '9.3', 'spread': '5.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Best Corrected Visual Acuity Right Eye (BCVA/OD)', 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.06', 'groupId': 'BG000'}, {'value': '0.02', 'spread': '0.06', 'groupId': 'BG001'}, {'value': '0.03', 'spread': '0.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Best Corrected Visual Acuity Left Eye (BCVA/OS)', 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.09', 'groupId': 'BG000'}, {'value': '0.03', 'spread': '0.07', 'groupId': 'BG001'}, {'value': '0.05', 'spread': '0.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'logMAR', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spherical Equivalent Refractive Error Right Eye (SE/0D)', 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.74', 'groupId': 'BG000'}, {'value': '-0.41', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '-0.22', 'spread': '1.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'diopter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Spherical Equivalent Refractive Error Left Eye (SE/OS)', 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.89', 'groupId': 'BG000'}, {'value': '-0.55', 'spread': '2.18', 'groupId': 'BG001'}, {'value': '-0.22', 'spread': '1.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'diopter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ocular Dominance Right Eye', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ocular Dominance Left Eye', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'preoperative distant deviation', 'classes': [{'categories': [{'measurements': [{'value': '36.25', 'spread': '9.01', 'groupId': 'BG000'}, {'value': '32.25', 'spread': '6.97', 'groupId': 'BG001'}, {'value': '34.25', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'prism diopter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'preoperative near deviation', 'classes': [{'categories': [{'measurements': [{'value': '36.25', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '32.75', 'spread': '7.51', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '8.97', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'prism diopter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fusion', 'classes': [{'categories': [{'title': 'positive fusion', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'absent fusion', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Assessment of binocular fusion by using Worth's dot test. Patients who can fuse are termed (positive fusion), and patients who can not fuse are termed (absent fusion).", 'unitOfMeasure': 'Participants'}, {'title': 'preoperative stereopsis', 'classes': [{'categories': [{'measurements': [{'value': '251', 'spread': '171.4', 'groupId': 'BG000'}, {'value': '263', 'spread': '172.4', 'groupId': 'BG001'}, {'value': '257', 'spread': '169.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'second of arc', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-15', 'size': 486963, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-11T06:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2022-01-20', 'resultsFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-26', 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ocular Alignment at Distant Fixation', 'timeFrame': 'one year', 'description': 'ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.'}, {'measure': 'Ocular Alignment at Near Fixation', 'timeFrame': 'one year', 'description': 'ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.'}], 'secondaryOutcomes': [{'measure': 'Sensory Status (Stereopsis)', 'timeFrame': 'one year', 'description': 'ocular sensory status (stereopsis) is assessed using Titmus fly test and is recorded as seconds of arc.'}, {'measure': 'Sensory Status (Fusion)', 'timeFrame': 'one year', 'description': 'Fusion is assessed using Worth 4-dot test, and is documented as present (positive fusion) or absent (absent fusion).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intermittent Exotropia']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.', 'detailedDescription': 'Surgical management of basic -type intermittent exotropia with a dominant eye is controversial. Some surgeons do traditional symmetrical bilateral lateral rectus recession, while other perform unilateral recess-resect procedure in the non-dominant eye. The aim of this study is to investigate the effect of two different strategies of bilateral lateral rectus recession; symmetrical recession in which the amount of recession is equally divided between both eyes, and asymmetrical recession, in which the amount of recession is 2mm more in the non-dominant. Outcome measures include ocular deviation at distant and near fixation, sensory status and complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Basic-type intermittent exotropia\n* Simulated distant-type intermittent exotropia\n\nExclusion Criteria:\n\n* Alternating basic-type intermittent exotropia (no ocular dominance)\n* Distant-type intermittent exotropia\n* Convergence-insufficiency type intermittent exotropia\n* Constant exotropia\n* Sensory exotropia\n* Deep amblyopia\n* Paralytic or restrictive exotropia\n* Previous extraocular muscle surgery'}, 'identificationModule': {'nctId': 'NCT05234957', 'acronym': 'IXT', 'briefTitle': 'Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Symmetric Versus Asymmetric Bilateral Lateral Rectus Recession in Management of Basic Intermittent Exotropia With Ocular Dominance', 'orgStudyIdInfo': {'id': 'RC1-1-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.', 'interventionNames': ['Procedure: Bilateral Lateral Rectus Recession']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.', 'interventionNames': ['Procedure: Bilateral Lateral Rectus Recession']}], 'interventions': [{'name': 'Bilateral Lateral Rectus Recession', 'type': 'PROCEDURE', 'description': 'Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Qalyubiyya', 'country': 'Egypt', 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Mohamed Farid, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohamed Fathy Farid', 'investigatorAffiliation': 'Benha University'}}}}