Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-04 @ 5:23 AM
Study NCT ID:
NCT01841957
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2013-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Simultaneous Bilateral Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2013-04-18', 'studyFirstSubmitQcDate': '2013-04-24', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '3 weeks', 'description': 'Best uncorrected and best spectacle corrected post-operative visual acuity'}], 'secondaryOutcomes': [{'measure': 'Recovery time and number of post-operative visits', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bilateral Cataract', 'Simultaneous Cataract Surgery', 'ISBCS'], 'conditions': ['Bilateral Cataract']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 30-100\n* Candidate for topical anesthesia\n* Signed the informed consents\n\nExclusion Criteria:\n\n* Allergies to medications used in study\n* Cannot have topical anesthesia\n* Unwilling to participate in research trial\n* Have any other significant ocular comorbidities\n* Have known systemic immuno-compromised state'}, 'identificationModule': {'nctId': 'NCT01841957', 'acronym': 'ISBCS', 'briefTitle': 'Immediate Simultaneous Bilateral Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Panhandle Eye Group, LLP'}, 'officialTitle': 'Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISBCS', 'description': 'Immediate Simultaneous Bilateral Cataract Surgery', 'interventionNames': ['Procedure: ISBCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DSBCS', 'description': 'Delayed Sequential Bilateral Cataract Surgery', 'interventionNames': ['Procedure: DSBCS']}], 'interventions': [{'name': 'ISBCS', 'type': 'PROCEDURE', 'description': 'same-day cataract surgery', 'armGroupLabels': ['ISBCS']}, {'name': 'DSBCS', 'type': 'PROCEDURE', 'description': 'bilateral surgery delayed by 1-3 weeks amongst eyes', 'armGroupLabels': ['DSBCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Panhandle Eye Group', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sloan W. Rush, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Sloan W. Rush, MD', 'investigatorAffiliation': 'Panhandle Eye Group, LLP'}}}}