Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 5:26 AM
Study NCT ID:
NCT00762606
Status:
COMPLETED
Last Update Posted:
2012-10-31
First Post:
2008-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@alconlabs.com', 'phone': '888.451.3937; 817.568.6725', 'title': 'Director of Alcon Clinical', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During surgery, 1 day,2 weeks, 1 month, 3 months,6 months and 12 months after surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Phaco', 'description': 'cataract extraction surgery utilizing Phacoemulsification', 'otherNumAtRisk': 55, 'otherNumAffected': 2, 'seriousNumAtRisk': 55, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'SICS', 'description': 'Small incision cataract surgery (SICS)', 'otherNumAtRisk': 51, 'otherNumAffected': 6, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Posterior Capsular Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders'}, {'term': 'Conjunctival Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Femoral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Zonular Rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Posterior Capsule Opacification Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phaco', 'description': 'cataract extraction surgery utilizing Phacoemulsification'}, {'id': 'OG001', 'title': 'SICS', 'description': 'Small incision cataract surgery (SICS)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months after surgery', 'description': 'The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Corneal Astigmatism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phaco', 'description': 'cataract extraction surgery utilizing Phacoemulsification'}, {'id': 'OG001', 'title': 'SICS', 'description': 'Small incision cataract surgery (SICS)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.05', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '1.95', 'spread': '1.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months after surgery', 'description': 'Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.', 'unitOfMeasure': 'Diopters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phaco', 'description': 'cataract extraction surgery utilizing Phacoemulsification'}, {'id': 'FG001', 'title': 'SICS', 'description': 'Small incision cataract surgery (SICS)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Phaco', 'description': 'cataract extraction surgery utilizing Phacoemulsification'}, {'id': 'BG001', 'title': 'SICS', 'description': 'Small incision cataract surgery (SICS)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2008-09-26', 'resultsFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2012-10-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-07', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posterior Capsule Opacification Evaluation', 'timeFrame': '12 months after surgery', 'description': 'The number of subjects with Posterior Capsular Opacification (PCO) for 12 months post-surgery of the study eye. PCO may occur after cataract surgery and is caused by residual lens epithelial cells that remain in the capsular bag after surgery and undergo proliferation, migration, and fibrous metaplasia. PCO was evaluated via slit lamp. A lower PCO rate is better.'}], 'secondaryOutcomes': [{'measure': 'Corneal Astigmatism', 'timeFrame': '3 months after surgery', 'description': 'Analysis of corneal astigmatism 12 months after surgery using Orbscan Topography. A lower corneal astigmatism value is better.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'To compare the health economic parameter and clinical outcome of Phacoemulsification with small incision cataract surgery (SICS)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has senile cataract and require unilateral cataract extraction followed by implantation of an AcrySof or PMMA (polymethylmethacrylate) posterior chamber intraocular lens (IOL);\n* Pupil dilation ≧7 mm after mydrisis;\n* Patient undergoing cataract surgery for the first eye;\n* VA prognosis ≧6/12\n\nExclusion Criteria:\n\n* Patients with history of ocular pathology or diabetic retinopathy;\n* Patients with traumatic, subluxated and posterior polar cataract;\n* Patients had ocular surgery in the past 6 months;\n* Patients with significant intra-operative complications'}, 'identificationModule': {'nctId': 'NCT00762606', 'briefTitle': 'Phaco Versus Small Incision Cataract Surgery (SICS) Health Economic Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Twelve-Months, Single-Masked, Parallel Group, Health Economic Study of Phacoemulsification Versus Small Incision Cataract Surgery (SICS) in Chinese Patients With Senile Cataract.', 'orgStudyIdInfo': {'id': 'RM-08-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phaco', 'description': 'Cataract extraction surgery utilizing Phacoemulsification', 'interventionNames': ['Procedure: Phacoemulsification cataract extraction surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SICS', 'description': 'Small incision cataract surgery (SICS)', 'interventionNames': ['Procedure: Small incision cataract surgery']}], 'interventions': [{'name': 'Phacoemulsification cataract extraction surgery', 'type': 'PROCEDURE', 'description': 'Surgical removal of cataract using phacoemulsification followed by implantation of an AcrySof Intraocular Lens (Model SN60WF)', 'armGroupLabels': ['Phaco']}, {'name': 'Small incision cataract surgery', 'type': 'PROCEDURE', 'description': 'Surgical removal of cataract using small incision cataract surgery (SICS) followed by implantation of a Polymethyl methacrylate(PMMA) Intraocular Lens (Model MZ60BD).', 'armGroupLabels': ['SICS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Alcon Call Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}