Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-20 @ 12:12 AM
Study NCT ID:
NCT00842959
Status:
COMPLETED
Last Update Posted:
2011-06-16
First Post:
2009-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-24', 'releaseDate': '2013-11-27'}], 'estimatedResultsFirstSubmitDate': '2013-11-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-15', 'studyFirstSubmitDate': '2009-02-11', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2011-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of prediction of target refraction', 'timeFrame': 'postop.'}, {'measure': 'Difference between calculated and measured contrast vision.', 'timeFrame': 'postop.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Improvement of adjustment accuracy of intraocular lenses and imaging quality'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified. Their implantation is clinical routine.\n\nIn the trial the accuracy of prediction of target refraction and the difference between calculated and measured contrast vision will be examined for both lens types.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for cataract operation\n* Written informed consent of patient after information\n\nExclusion Criteria:\n\n* Immobility\n* Limited capacity of understanding\n* Diseases that hamper a follow-up examination\n* Astigmatism \\>2.0 D\n* Patients with ocular diseases who may be expected to show a vision of less than 0.63 (decimal) two months after cataract surgery with implantation of intraocular lens\n* Complications during surgery, especially complications with positioning of the intraocular lens and with capsulorhexis'}, 'identificationModule': {'nctId': 'NCT00842959', 'acronym': 'ZO Okulix', 'briefTitle': 'Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'Check of Optical Features and Accuracy of the Zeiss ZO Lens of the Company Carl Zeiss Meditec After Selection and Calculation With OKULIX', 'orgStudyIdInfo': {'id': 'Acri.Tec-RES-DE-273'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ZO', 'description': 'XL Stabi ZO or Invent ZO', 'interventionNames': ['Device: Invent ZO', 'Device: XL Stabi ZO']}], 'interventions': [{'name': 'Invent ZO', 'type': 'DEVICE', 'description': 'monofocal aspheric IOL for implantation into capsular bag', 'armGroupLabels': ['ZO']}, {'name': 'XL Stabi ZO', 'type': 'DEVICE', 'description': 'monofocal aspheric IOL for implantation into capsular bag', 'armGroupLabels': ['ZO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitäts-Augenklinik Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Jochen Wahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäts-Augenklinik Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Andreas Langer', 'oldOrganization': 'Acri.Tec GmbH'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-11-27', 'type': 'RELEASE'}, {'date': '2014-01-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Carl Zeiss Meditec AG'}}}}