Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-01-09 @ 1:42 PM
Study NCT ID:
NCT03247751
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2017-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Rotational Stability
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': 'D007910', 'term': 'Lenses, Intraocular'}], 'ancestors': [{'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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-06', 'studyFirstSubmitDate': '2017-06-16', 'studyFirstSubmitQcDate': '2017-08-08', 'lastUpdatePostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The intraocular lens rotation', 'timeFrame': 'postoperative 6 months', 'description': 'The angle of the intraocular rotation.'}], 'secondaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': 'postoperative 6 months', 'description': 'Distance BCVA'}, {'measure': 'Adverse event', 'timeFrame': 'postoperative 6 months', 'description': 'severity and causal relationship'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'To evaluate rotational stability of the investigational device implanted after cataract surgery.', 'detailedDescription': 'The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, 18 years or older\n* Subject who diagnosed unilateral or bilateral age-related cataract.\n* Potential postoperative BCVA of 0.2 log MAR (0.63) or better.\n* Calculated IOL power in within the range of investigational IOL.\n* Subject is able to understand, agree and sign the informed consent statement.\n* Subject is able and willing to comply with the postoperative follow-up examination schedule.\n\nExclusion Criteria:\n\n* Uncontrolled systemic or ocular disease.\n* Extremely shallow anterior chamber.\n* Previous intraocular and corneal surgery.\n* Traumatic cataract.\n* Pregnancy or lactation.\n* Concurrent participation in another drug and device clinical investigation.'}, 'identificationModule': {'nctId': 'NCT03247751', 'briefTitle': 'Evaluation of the Rotational Stability', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nidek Co. LTD.'}, 'officialTitle': 'Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens', 'orgStudyIdInfo': {'id': 'BPF001C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one group', 'description': 'one group receiving NIDEK intraocular lens', 'interventionNames': ['Device: intraocular lens']}], 'interventions': [{'name': 'intraocular lens', 'type': 'DEVICE', 'description': 'Implant NIDEK intraocular lens after cataract surgery', 'armGroupLabels': ['one group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nidek Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}