Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT01786356
Status:
COMPLETED
Last Update Posted:
2013-02-07
First Post:
2013-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D058442', 'term': 'Capsule Opacification'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-05', 'studyFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2013-02-05', 'lastUpdatePostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'posterior capsular opacification (PCO)', 'timeFrame': '4 years', 'description': 'subjective and objective PCO scoring'}], 'secondaryOutcomes': [{'measure': 'best corrected visual acuity (BCVA)', 'timeFrame': '4 years'}, {'measure': 'Nd:YAG rate', 'timeFrame': '4 years'}]}, 'conditionsModule': {'keywords': ['posterior capsule opacification', 'PCO', 'after cataract', 'intraocular lens'], 'conditions': ['Posterior Capsule Opacification', 'Cataract']}, 'descriptionModule': {'briefSummary': "Age-related cataract is the main cause of impaired vision in the elderly population worldwide.\n\nThe only treatment that can restore functional visual ability is cataract surgery where the opacified crystalline lens is removed by phacoemulsification and an artificial intraocular lens is implanted into the remaining capsular bag. Cataract operations are generally very successful, with a low risk of serious complications.\n\nThe most common reason for impaired vision after uneventful cataract surgery in otherwise healthy eyes is the development of posterior capsule opacification (PCO). PCO is a physiological change (thickening, opacification and clouding) of the capsular bag expected after cataract surgery, because the lens epithelial cells (LECs) undergo hyperplasia and cellular migration. PCO is treated with Nd:YAG capsulotomy, a quick outpatient procedure that uses a laser to open a central hole in the posterior capsular bag.\n\nModifications in IOL design and material lead to a decrease in the incidence of PCO.\n\nDuring the past two decades, refinements in surgical technique were made resulting in today's small incision phacoemulsification surgery. Nowadays a multitude of microincision IOLs are available, many of them similar but of course with some differences in regard to the chemical composition of the acrylic material and the IOL design.\n\nThe purpose of this study is to compare the development of posterior capsule opacification (PCO) and the frequency of treatment between two different microincision IOLs over a period of 4 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bilateral age-related cataract\n* good overall physical constitution\n\nExclusion Criteria:\n\n* previous intraocular surgery or ocular trauma\n* intraocular complication like posterior capsular tear\n* glaucoma\n* uveitis\n* corneal diseases, diabetic retinopathy and any other severe retinal pathology that would make a postoperative visual acuity of 20/40 (decimal equivalent = 0.5) or better unlikely'}, 'identificationModule': {'nctId': 'NCT01786356', 'briefTitle': 'Posterior Capsule Opacification and Frequency of Nd:YAG Treatment and of Two IOLs: Hoya iMics Y-60H vs. Bausch&Lomb MI60 (MIMI)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'orgStudyIdInfo': {'id': 'EK Nr: 931/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HOYA iMics Y-60H', 'description': 'eyes with implanted intraocular lens HOYA iMics Y-60H', 'interventionNames': ['Device: HOYA iMics Y-60H']}, {'type': 'OTHER', 'label': 'B&L MI60', 'description': 'eyes with implanted intraocular lens B\\&L MI60', 'interventionNames': ['Other: B&L MI60']}], 'interventions': [{'name': 'HOYA iMics Y-60H', 'type': 'DEVICE', 'description': 'same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye', 'armGroupLabels': ['HOYA iMics Y-60H']}, {'name': 'B&L MI60', 'type': 'OTHER', 'description': 'same-day bilateral cataract surgery with implantation of intraocular lens B\\&L MI60 in one eye', 'armGroupLabels': ['B&L MI60']}]}, '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'}}}}