Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-30 @ 5:34 AM
Study NCT ID:
NCT02649257
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D007910', 'term': 'Lenses, Intraocular'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOL rotation', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['IOL rotation', 'capsular tension ring', 'IOL rotational stability'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 AS IOL.\n\nAt the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation\n\nExclusion Criteria:\n\n* Preceding ocular surgery or trauma\n* Recurrent intraocular inflammation of unknown etiology\n* Uncontrolled glaucoma\n* Uncontrolled systemic or ocular disease\n* Blind fellow eye\n* Microphthalmus\n* Corneal abnormality\n* History of uveitis/iritis\n* Iris neovascularization\n* Pseudoexfoliation\n* Proliferative diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT02649257', 'briefTitle': 'Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)', 'orgStudyIdInfo': {'id': 'EK-Nr.: 1435/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MC 6125 AS IOL + CTR', 'description': 'All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).', 'interventionNames': ['Procedure: cataract surgery', 'Device: intraocular lens (MC 6125 AS)', 'Device: capsular tension ring (CTR 13/11)']}], 'interventions': [{'name': 'cataract surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['MC 6125 AS IOL + CTR']}, {'name': 'intraocular lens (MC 6125 AS)', 'type': 'DEVICE', 'armGroupLabels': ['MC 6125 AS IOL + CTR']}, {'name': 'capsular tension ring (CTR 13/11)', 'type': 'DEVICE', 'armGroupLabels': ['MC 6125 AS IOL + CTR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vianne', 'country': 'Austria', 'facility': 'Department of Ophthalmology and Optometry of the Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ao.Univ.-Prof. Dr.med.univ.', 'investigatorFullName': 'Rupert Menapace', 'investigatorAffiliation': 'Medical University of Vienna'}}}}