Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-30 @ 1:26 PM
Study NCT ID:
NCT01045733
Status:
COMPLETED
Last Update Posted:
2012-11-29
First Post:
2010-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D001251', 'term': 'Astigmatism'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2010-01-08', 'studyFirstSubmitQcDate': '2010-01-08', 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corneal Aberration', 'timeFrame': 'Month 6 postoperative'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Month 6 postoperative'}, {'measure': 'Corneal Cylinder', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cataract', 'Toric', 'IOL', 'AcrySof', 'LRI', 'Astigmatism'], 'conditions': ['Cataract', 'Astigmatism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate and compare postoperative corneal aberrations and visual parameters in patients contralaterally implanted with an AcrySof IQ Toric intraocular lens (IOL) and AcrySof IQ Aspheric IOL with concomitant limbal relaxing incision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nOcular criteria must be met in both eyes.\n\n* Willing and able to understand and sign an informed consent;\n* Willing and able to attend postoperative examinations per protocol schedule;\n* Have cataracts that require extraction followed by implantation of a posterior chamber intraocular lens and used as an on-label procedure;\n* Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and AcrySof IQ Toric package inserts;\n* Have regular, bowtie shaped corneal astigmatism and qualify for an SN6AT3, SN6AT4 or SN6AT5 Intraocular Lens (IOL) in both eyes;\n* Have the second surgery at least one week following the first eye implant but not later than one month after the first implant.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Previous corneal surgery;\n* Planned multiple procedures during cataract/IOL implantation surgery;\n* Ocular disease and/or condition that may compromise study results;\n* Pregnant or planning pregnancy during course of study;\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01045733', 'briefTitle': 'A Comparison of Corneal Aberrations in Subjects With Contralateral AcrySof IQ Toric Intraocular Lens (IOL) and AcrySof IQ IOL With Limbal Relaxing Incision (LRI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Prospective Contralateral Comparison of Corneal Aberrations in Subjects Undergoing Aspheric Lens Implantation With Concomitant LRI and Aspheric Toric IOL Implantation', 'orgStudyIdInfo': {'id': 'M-09-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IQ Toric IOL', 'description': 'AcrySof IQ Toric intraocular lens (IOL) randomly assigned to one eye, with AcrySof IQ Aspheric IOL with Limbal Relaxing Incision (LRI) procedure in the fellow eye for contralateral implantation.', 'interventionNames': ['Device: AcrySof IQ Toric IOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IQ Aspheric IOL + LRI', 'description': 'AcrySof IQ Aspheric intraocular lens (IOL) with Limbal Relaxing Incision (LRI) procedure randomly assigned to one eye, with AcrySof IQ Toric IOL in the fellow eye for contralateral implantation', 'interventionNames': ['Device: AcrySof IQ Aspheric IOL', 'Procedure: Limbal Relaxing Incision (LRI)']}], 'interventions': [{'name': 'AcrySof IQ Toric IOL', 'type': 'DEVICE', 'otherNames': ['AcrySof IQ Toric IOL Model SN6AT3', 'AcrySof IQ Toric IOL Model SN6AT4', 'AcrySof IQ Toric IOL Model SN6AT5'], 'description': 'AcrySof IQ Toric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.', 'armGroupLabels': ['IQ Toric IOL']}, {'name': 'AcrySof IQ Aspheric IOL', 'type': 'DEVICE', 'otherNames': ['AcrySof IQ Aspheric IOL Model SN60WF'], 'description': 'AcrySof IQ aspheric intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient.', 'armGroupLabels': ['IQ Aspheric IOL + LRI']}, {'name': 'Limbal Relaxing Incision (LRI)', 'type': 'PROCEDURE', 'description': 'An incision was made at the corneal-limbal junction during cataract surgery for the purpose of relaxing corneal curvature, ie., correcting astigmatism.', 'armGroupLabels': ['IQ Aspheric IOL + LRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}