Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-02 @ 2:07 AM
Study NCT ID:
NCT02208232
Status:
COMPLETED
Last Update Posted:
2014-08-05
First Post:
2014-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Rotation of an Intraocular Lens
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'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-01', 'studyFirstSubmitDate': '2014-03-27', 'studyFirstSubmitQcDate': '2014-08-01', 'lastUpdatePostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOL rotation', 'timeFrame': '6 months', 'description': 'The rotation of the IOLs over the first 6 postoperative months'}]}, 'conditionsModule': {'keywords': ['IOL rotation'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 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', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the Department of Ophthalmology, Medical University Vienna.', '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': 'NCT02208232', 'briefTitle': 'Observation of Rotation of an Intraocular Lens', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Observation of Rotation of the MC 6125 AS Intraocular Lens', 'orgStudyIdInfo': {'id': 'EK Nr: 1267/2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MC 6125 AS IOL', 'description': 'cataract surgery with implantation of intraocular lens MC 6125 AS in one eye', 'interventionNames': ['Procedure: cataract surgery']}], 'interventions': [{'name': 'cataract surgery', 'type': 'PROCEDURE', 'description': 'cataract surgery with implantation of intraocular lens', 'armGroupLabels': ['MC 6125 AS IOL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', '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'}}}}