Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
Study NCT ID:
NCT00759668
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2008-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)
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': 'marcello.fornoni@alconlabs.com', 'phone': '39.02.81.303.226', 'title': 'Marcello Fornoni', 'organization': 'Alcon Italia SpA'}, 'certainAgreement': {'otherDetails': 'Any formal presentation of data publication from this study has to be a joint presentation from both the Investigators and the Sponsor. Being the study multicentric, it is mandatory that the first publication is based on data from all the centres, analysed according to the protocol. Data from a single Centre can not be presented, unless there is a formal agreement from the other Investigators and Alcon.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Visual acuity data were collected in different units (i.e. c, twentieth, decimal, Jaeger) and were converted to LogMAR after inclusion in the database. This led to inevitable approximations of the data.'}}, 'adverseEventsModule': {'timeFrame': 'Visit 2 (1st eye implant) through Visit 8 (6 months following 2nd implant)', 'eventGroups': [{'id': 'EG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3', 'otherNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT', 'otherNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 118, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA, v11.0'}, {'term': 'hernia hiatal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA, v11.0'}, {'term': 'Stenosis and insufficiency of lacrimal passages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA, v11.0'}, {'term': 'Corneal membrane disorder NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA, v11.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA, v11.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA, v11.0'}], 'seriousEvents': [{'term': 'Aortic aneurysm', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA, v11.0'}, {'term': 'Breast cancer', 'notes': 'Not device related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'MedDRA, v11.0'}], 'frequencyThreshold': '1.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Near Best Corrected Visual Acuity (BCVA) - Binocular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'OG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \\& were converted to LogMAR after inclusion in the database leading to data approximations.'}, {'type': 'PRIMARY', 'title': 'Near Uncorrected Visual Acuity (UCVA) Binocular', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'OG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '31.25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \\& were converted to LogMAR after inclusion in the database leading to data approximations.'}, {'type': 'PRIMARY', 'title': 'Near Best Corrected Visual Acuity Left Eye (BCVA LE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'OG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'classes': [{'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \\& were converted to LogMAR after inclusion in the database leading to data approximations.'}, {'type': 'PRIMARY', 'title': 'Near Uncorrected Visual Acuity Left Eye (UCVA LE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'OG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '18.75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \\& were converted to LogMAR after inclusion in the database leading to data approximations.'}, {'type': 'PRIMARY', 'title': 'Near Best Corrected Visual Acuity Right Eye (BCVA RE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'OG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'classes': [{'categories': [{'measurements': [{'value': '68.75', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \\& were converted to LogMAR after inclusion in the database leading to data approximations.'}, {'type': 'PRIMARY', 'title': 'Near Uncorrected Visual Acuity Right Eye (UCVA RE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'OG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The # of subjects analyzed does not match the # of subjects in the participant flow as Near Visual Acuity (VA) was analyzed in the Intent To Treat population (N=16 for both groups). VA data were collected in different units (ie c, twentieth, decimal, Jaeger) \\& were converted to LogMAR after inclusion in the database leading to data approximations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'FG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': '35 patients, diagnosed with bilateral cataracts age related, requiring extraction of cataracts in both eyes followed by implantation of a posterior chamber intraocular lens, were recruited.', 'preAssignmentDetails': 'Patients meeting the inclusion/exclusion criteria were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SN60D3', 'description': 'Intraocular Lens Acrysof Natural Restor SN60D3'}, {'id': 'BG001', 'title': 'SN60AT', 'description': 'Intraocular Lens Acrysof Natural Monofocal SN60AT'}, {'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': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-05', 'studyFirstSubmitDate': '2008-09-24', 'resultsFirstSubmitDate': '2010-10-12', 'studyFirstSubmitQcDate': '2008-09-24', 'lastUpdatePostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-01-05', 'studyFirstPostDateStruct': {'date': '2008-09-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Near Best Corrected Visual Acuity (BCVA) - Binocular', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.'}, {'measure': 'Near Uncorrected Visual Acuity (UCVA) Binocular', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted binocularly and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.'}, {'measure': 'Near Best Corrected Visual Acuity Left Eye (BCVA LE)', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.'}, {'measure': 'Near Uncorrected Visual Acuity Left Eye (UCVA LE)', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (left eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.'}, {'measure': 'Near Best Corrected Visual Acuity Right Eye (BCVA RE)', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with best correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.'}, {'measure': 'Near Uncorrected Visual Acuity Right Eye (UCVA RE)', 'timeFrame': '6 months after second eye implantation', 'description': 'Percentage of patients with Near Visual Acuity (VA) ≥ 6.5/10 (≤ 0.18 LogMAR) at visit 8 (six months after implantation of the 2nd eye). This test was conducted monocularly (right eye only) and with no correction. The effect of treatment was tested by Chi-square test. VA is acuteness or clearness of vision, which is dependent on the sharpness of the retinal focus within the eye and the sensitivity of the interpretative faculty of the brain. VA is measured in logMAR which is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is:\n\n* to compare visual parameters (Subjective refraction and Visual Acuity (VA)) and safety (tilt, decentration and posterior chamber opacification (PCO)) in a prospective series of 40 patients after bilateral implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)\n* to assess patient satisfaction before and after implant'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Written informed consent\n* Age: ≥ 50 years ≤ 75 years\n* Bilateral age related cataract, to be extracted and followed by the implantation of Posterior Chamber Intraocular Lenses (IOLs)\n* Pre-operative and post-operative astigmatism ≤ 1 Diopter (D), as from Keratometry readings\n* Potential post operative Visual Acuity (VA) ≥ 20/40\n* Second eye surgery to take place no longer than 45 days after the first implant\n\nExclusion:\n\n* Irregular optical aberrations;\n* Pupil diameter in scotopic conditions more than 6 mm\n* Degenerative visual pathologies (ex: Age-related Macular Degeneration (AMD))\n* Other exclusions as from ReSTOR Directions for Use (DFU)'}, 'identificationModule': {'nctId': 'NCT00759668', 'briefTitle': 'Visual Function and Patient Satisfaction After Bilateral Implantation of AcrySof Natural ReSTOR (Model SN60D3) or AcrySof Natural Monofocal (Model SN60AT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'IT 06 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SN60D3', 'description': 'AcrySof Natural ReSTOR Intraocular Lens (IOL) Model SN60D3', 'interventionNames': ['Device: Acrysof Natural ReSTOR SN60D3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SN60AT', 'description': 'AcrySof Natural Monofocal Intraocular Lens (IOL) Model SN60AT', 'interventionNames': ['Device: Acrysof Natural Monofocal SN60AT']}], 'interventions': [{'name': 'Acrysof Natural ReSTOR SN60D3', 'type': 'DEVICE', 'description': 'Bilateral implantation with the AcrySof Natural ReSTOR Intraocular Lens (IOL) SN60D3 following cataract removal.', 'armGroupLabels': ['SN60D3']}, {'name': 'Acrysof Natural Monofocal SN60AT', 'type': 'DEVICE', 'description': 'Bilateral implantation with the AcrySof Natural Intraocular Lens (IOL) Model SN60AT following cataract removal.', 'armGroupLabels': ['SN60AT']}]}, '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': {'oldNameTitle': 'Marcello Fornoni', 'oldOrganization': 'Alcon'}}}}