Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:51 AM
Study NCT ID:
NCT03454334
Status:
TERMINATED
Last Update Posted:
2022-04-18
First Post:
2018-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Performance of Four Types of Multifocal 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000075542', 'term': 'Multifocal Intraocular Lenses'}], 'ancestors': [{'id': 'D007910', 'term': 'Lenses, Intraocular'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-10', 'studyFirstSubmitDate': '2018-01-25', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast sensitivity', 'timeFrame': '4 years', 'description': 'mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P\\<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preoperative BCVA (distance) more impacted than 20/40\n* Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.\n* By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.\n* Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities\n\nExclusion Criteria:\n\n* Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.\n* Large pupil\n* Corneal transplant surgery or previous glaucoma-filtering,\n* A history of retinal detachments.\n* Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,\n* Endothelial disease\n* Iris neovascularization, and amblyopia)'}, 'identificationModule': {'nctId': 'NCT03454334', 'acronym': 'presbyopia', 'briefTitle': 'Visual Performance of Four Types of Multifocal Intraocular Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University'}, 'officialTitle': 'To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts', 'orgStudyIdInfo': {'id': 'ShahedBU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'AMO Tecnis Symfony', 'description': 'Multifocal with extended range of vision, Diffractive, No Preloaded, Aspheric, +3.25 D near add and +2.17 D intermediate 6.0mm Hydrophilic\n\n-0.20\n\nHas nine diffractive steps, The proprietary achromatic technology corrects chromatic aberration. This creates improved contrast sensitivity.', 'interventionNames': ['Device: multifocal intraocular lens IOLs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AcrySof ReSTOR (Alcon Laboratories)', 'description': 'Multifocal ,Diffractive, +3.00D and for Near, Aspheric, Has 9 steps (rings), Light: 41% for far; 41% for near: 18% reflected (lost).\n\n6.0mm Silicone\n\n-0.10 Bifocal ,One piece,Blue filter ,Central diffractive region of 3.6\\_mm for near and distance vision ,Apodised ,peripheral refractive region is dedicated to distance vision', 'interventionNames': ['Device: multifocal intraocular lens IOLs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AT Lisa tri (CarlZeiss Meditec AG)', 'description': 'Trifocal, diffractive, +3.33 D near add and +1.66 D intermediate add at the IOL plane, aspheric (aberration correcting) Optic Diameter 6.0 mm Total Diameter 11.0 mm Haptic Angulation 0° Lens Design Single-piece, MICS Incision Size 1.8 mm Company Labeled A-Constant1 118.6 Diopter Range 0.0 to +32.0 D, 0.5 D increments ACD 5.32', 'interventionNames': ['Device: multifocal intraocular lens IOLs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PanOptix(Alcon Laboratories)', 'description': 'Trifocal,Difractive,+3.25D Near,+2.17 D intermediate 6.0mm hydrophobic\n\n-0.27 One piece ,aspheric , Focal 4.5 mm (15 diffractive zones)', 'interventionNames': ['Device: multifocal intraocular lens IOLs']}], 'interventions': [{'name': 'multifocal intraocular lens IOLs', 'type': 'DEVICE', 'description': 'clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts', 'armGroupLabels': ['AMO Tecnis Symfony', 'AT Lisa tri (CarlZeiss Meditec AG)', 'AcrySof ReSTOR (Alcon Laboratories)', 'PanOptix(Alcon Laboratories)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist', 'investigatorFullName': 'farinaz doroodgar', 'investigatorAffiliation': 'Shahid Beheshti University'}}}}