Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-03-15 @ 4:40 AM
Study NCT ID:
NCT02234635
Status:
UNKNOWN
Last Update Posted:
2014-09-09
First Post:
2014-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015352', 'term': 'Dry Eye Syndromes'}, {'id': 'D014786', 'term': 'Vision Disorders'}], 'ancestors': [{'id': 'D007766', 'term': 'Lacrimal Apparatus Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens', 'timeFrame': '1week, 1month, 3month,6month,12month', 'description': 'Visual quality change during the first year after cataract surgery. The visual quality including the subjective and objective visual quality. The subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) and distance corrected near visual acuity (DCNVA).\n\nThe objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI) and OQAS value (OV).'}], 'secondaryOutcomes': [{'measure': 'To evaluate the Tear-film Quality Dynamics of Eyes Implanted With Diffractive Multifocal Intraocular Lens', 'timeFrame': '1week, 1month, 3month,6month,12month', 'description': 'The tear-film quality dynamics including the tear break-up time and the tear-film OSI were examined by optical quality analysis system (OQAS)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['visual acuity', 'objective visual quality', 'multifocal intraocular lens', 'tear-film quality dynamics'], 'conditions': ['Dry Eye', 'Vision Disorders', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '33569446', 'type': 'DERIVED', 'citation': 'Ye L, Chen T, Hu Z, Yang Q, Su Q, Li J. Comparison of the visual performance between Oculentis MF30 and Tecnis ZMB00 multifocal intraocular lenses. Ann Transl Med. 2021 Jan;9(2):144. doi: 10.21037/atm-20-7777.'}, {'pmid': '26903522', 'type': 'DERIVED', 'citation': 'Chen T, Yu F, Lin H, Zhao Y, Chang P, Lin L, Chen Q, Zheng Q, Zhao YE, Lu F, Li J. Objective and subjective visual quality after implantation of all optic zone diffractive multifocal intraocular lenses: a prospective, case-control observational study. Br J Ophthalmol. 2016 Nov;100(11):1530-1535. doi: 10.1136/bjophthalmol-2015-307135. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators examined the subjective visual quality including LogMAR uncorrected distance visual acuity (UCDVA), best corrected distance visual acuity (BCDVA),uncorrected intermediate visual acuity (UCIVA), distance corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (UCNVA) ,distance corrected near visual acuity (DCNVA),using logMAR visual acuity chart,and the objective visual quality including Modulation Transfer Function (MTF), Strehl ratio(SR), objective scatter index (OSI), OQAS value (OV),and the tear-film quality dynamics including the tear break-up time and the tear-film OSI between the eyes with multifocal lens and monofocal lenses by optical quality analysis system (OQAS).', 'detailedDescription': '50 eyes of 50 cataract patients scheduled for phacoemulsification surgery were recruited, the multifocal group (25 eyes) ，were implantation with Tecnis® ZMB00；and the monofocal group (25 eyes) were implantation with Tecnis® ZCB00.\n\nMethods: All eyes were examined by logMAR visual acuity chart and Optical quality analysis system (OQAS) at 1 week, 1 month, 3 month, 6 month,12 month after surgery for the subjective and objective visual quality Change during the first year.\n\nMeasures:Subjective and objective visual quality were evaluated.Tear-film quality dynamicswere evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eyes with an axial length of 22.00 to 25.00 mm with age-related cataract.\n\nExclusion Criteria:\n\n* Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation.\n* Patients who could not be available for follow-up.'}, 'identificationModule': {'nctId': 'NCT02234635', 'briefTitle': 'Visual Quality Change of Eyes Implanted With Diffractive Multifocal Intraocular Lens After Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Phase 1 Evaluate the Visual Quality Change of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses; Phase 2 Evaluate the Tear Film Quality Dynamics of Eyes Implanted With Multifocal Intraocular Lens and Monofocal Lenses.', 'orgStudyIdInfo': {'id': 'VQIOL-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'monofocal IOLs group', 'description': 'monofocal IOLs group were implantation with Tecnis® ZCB00', 'interventionNames': ['Other: Diffractive multifocal IOLs group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diffractive multifocal IOLs group', 'description': 'Diffractive multifocal IOLs group were implantation with Tecnis® ZMB00', 'interventionNames': ['Other: Diffractive multifocal IOLs group']}], 'interventions': [{'name': 'Diffractive multifocal IOLs group', 'type': 'OTHER', 'description': 'Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.', 'armGroupLabels': ['Diffractive multifocal IOLs group', 'monofocal IOLs group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '325000', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang, Yu', 'role': 'CONTACT', 'email': '357574103@qq.com', 'phone': '13758452287'}], 'facility': 'Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Fang Yu', 'role': 'CONTACT', 'email': '357574103@qq.com', 'phone': '13758452287'}], 'overallOfficials': [{'name': 'Fang Yu', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Affiliated Eye Hospital of Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor of ophthalmology, Principal Investigator, Clinical Professor', 'investigatorFullName': 'yin ying zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}