Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT01615861
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2012-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2015-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2012-05-29', 'studyFirstSubmitQcDate': '2012-06-07', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '6 months', 'description': 'Corrected distance visual acuity (CDVA)'}], 'secondaryOutcomes': [{'measure': 'Incision size', 'timeFrame': '6 Months', 'description': 'Incision size before and after implantation'}, {'measure': 'Refraction', 'timeFrame': '6 Months', 'description': 'Manifest refraction spherical equivalent. Accuracy to target refraction'}, {'measure': 'Visual Acuity', 'timeFrame': '6 Months', 'description': 'Uncorrected distance visual acuity (UDVA)'}, {'measure': 'EPCO', 'timeFrame': '24 Months', 'description': '3 mm evaluation of posterior capsule opacification (EPCO) score'}, {'measure': 'Lens decentration', 'timeFrame': '6 Months'}, {'measure': 'Laser capsulotomy', 'timeFrame': '24 Months', 'description': 'Removal of post-surgical, posterior capsular opacification (PCO)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases\n\n* V4 (6M) endpoint: primary analysis\n* V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have clear intraocular media other than cataract in the study eye.\n* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.\n\nExclusion Criteria:\n\n* Subjects with ocular malformation in the study eye.\n* Subjects who have had previous surgery in the study eye.\n* Subjects with uncontrolled glaucoma in either eye.\n* Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated\n* Subjects using medications known to potentially complicate cataract surgery.'}, 'identificationModule': {'nctId': 'NCT01615861', 'briefTitle': 'Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch & Lomb Incorporated'}, 'officialTitle': 'Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens', 'orgStudyIdInfo': {'id': '714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IOL implantation', 'description': 'Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)', 'interventionNames': ['Procedure: IOL implantation', 'Device: IOL Implantation']}], 'interventions': [{'name': 'IOL implantation', 'type': 'PROCEDURE', 'description': 'Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.', 'armGroupLabels': ['IOL implantation']}, {'name': 'IOL Implantation', 'type': 'DEVICE', 'description': 'Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.', 'armGroupLabels': ['IOL implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31670', 'city': 'Labège', 'country': 'France', 'facility': 'Bausch & Lomb', 'geoPoint': {'lat': 43.52935, 'lon': 1.52999}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch & Lomb Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}