Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-07-16 @ 7:28 PM
Study NCT ID:
NCT03145103
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-17', 'studyFirstSubmitDate': '2017-05-05', 'studyFirstSubmitQcDate': '2017-05-05', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '12 to 18 months after surgery', 'description': 'Monocular best corrected distance visual acuity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '32527240', 'type': 'DERIVED', 'citation': 'Johansson B, Daniel ACS, Herbers C, Gerl M, Kretz FTA. Clinical safety and efficacy of a hydrophilic acrylic intraocular lens in a real-world population: a 1-year follow-up retro-prospective study. BMC Ophthalmol. 2020 Jun 11;20(1):224. doi: 10.1186/s12886-020-01493-y.'}]}, 'descriptionModule': {'briefSummary': 'Clinical safety and efficacy of CT ASPHINA 409 IOLs after implantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;\n* Patients of any gender\n* Assured follow-up examinations\n* Biometry measurement preferably compatible with the IOLMaster evaluation;\n* IOL implanted into the capsular bag with IOL model CT ASPHINA 409MP (UVE material) in one eye with at least 12 months follow up at the time of the postop visit\n* Patients who had uncomplicated (no peroperative complication) aged-related cataract surgery in a healthy eye (beside clinically significant cataract)\n\nExclusion Criteria:\n\n* BCVA not available preoperatively or better than 0.3 logMAR pre-op\n* Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial\n* Patients whose freedom is impaired by administrative or legal order\n* Concurrent participation in another drug or device investigation -'}, 'identificationModule': {'nctId': 'NCT03145103', 'acronym': 'UVEA409', 'briefTitle': 'Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'Clinical Safety and Efficacy of Hydrophilic Acrylic Intraocular Lenses - Retro Prospective Study', 'orgStudyIdInfo': {'id': 'ASPHINA 409-BER-401-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '409M', 'description': 'CT ASPHINA 409M IOL', 'interventionNames': ['Device: CT ASPHINA 409']}], 'interventions': [{'name': 'CT ASPHINA 409', 'type': 'DEVICE', 'description': 'intraocular lens', 'armGroupLabels': ['409M']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE58252', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}