Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT01027533
Status:
COMPLETED
Last Update Posted:
2010-07-02
First Post:
2009-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-01', 'studyFirstSubmitDate': '2009-12-07', 'studyFirstSubmitQcDate': '2009-12-07', 'lastUpdatePostDateStruct': {'date': '2010-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distance,intermediate and near visual acuity', 'timeFrame': '1, 3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'reading speed and contrast sensitivity', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['multifocal intraocular lens', 'visual acuity', 'presbiopia'], 'conditions': ['To Study the Influence of an Multifocal Intraocular Lens With Different Addition on Intermediate Visual Acuity']}, 'referencesModule': {'references': [{'pmid': '19631128', 'type': 'BACKGROUND', 'citation': 'Gupta N, Wolffsohn JS, Naroo SA. Comparison of near visual acuity and reading metrics in presbyopia correction. J Cataract Refract Surg. 2009 Aug;35(8):1401-9. doi: 10.1016/j.jcrs.2009.03.026.'}, {'pmid': '19545814', 'type': 'BACKGROUND', 'citation': 'Biber JM, Sandoval HP, Trivedi RH, de Castro LE, French JW, Solomon KD. Comparison of the incidence and visual significance of posterior capsule opacification between multifocal spherical, monofocal spherical, and monofocal aspheric intraocular lenses. J Cataract Refract Surg. 2009 Jul;35(7):1234-8. doi: 10.1016/j.jcrs.2009.03.013.'}, {'pmid': '19393889', 'type': 'BACKGROUND', 'citation': 'Alfonso JF, Fernandez-Vega L, Amhaz H, Montes-Mico R, Valcarcel B, Ferrer-Blasco T. Visual function after implantation of an aspheric bifocal intraocular lens. J Cataract Refract Surg. 2009 May;35(5):885-92. doi: 10.1016/j.jcrs.2009.01.014.'}, {'pmid': '19152978', 'type': 'BACKGROUND', 'citation': 'Hayashi K, Yoshida M, Hayashi H. All-distance visual acuity and contrast visual acuity in eyes with a refractive multifocal intraocular lens with minimal added power. Ophthalmology. 2009 Mar;116(3):401-8. doi: 10.1016/j.ophtha.2008.09.052. Epub 2009 Jan 18.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.\n\nStudy hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.", 'detailedDescription': 'Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.\n\nPatients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The sutdy population will be patients implanted bilaterally with the selected multifocal IOL', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)\n\nExclusion Criteria:\n\n* Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities\n* Surgical complications\n* Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)\n* Incomplete follow-up.'}, 'identificationModule': {'nctId': 'NCT01027533', 'briefTitle': 'Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'orgStudyIdInfo': {'id': 'MRS.1703'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Restor +3', 'description': 'patients will be implanted bilaterally with Restor + 3', 'interventionNames': ['Other: Implantation of a multifocal Intraocular lens']}, {'label': 'restor +4', 'description': 'Patients will be implanted bilaterally with Restor +4', 'interventionNames': ['Other: Implantation of a multifocal Intraocular lens']}], 'interventions': [{'name': 'Implantation of a multifocal Intraocular lens', 'type': 'OTHER', 'otherNames': ['Restor + 3 SN6AD1', 'Restor + 4 SN6AD3'], 'description': 'Bilateral implantation of a multifocal IOl', 'armGroupLabels': ['Restor +3', 'restor +4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '054000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Marcony Santhiago, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Marcony R Santhiago', 'oldOrganization': 'University of São Paulo'}}}}