Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-20 @ 12:38 PM
Study NCT ID:
NCT02838004
Status:
COMPLETED
Last Update Posted:
2020-01-14
First Post:
2016-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Romania'], 'submissionTracking': {'submissionInfos': [{'releaseDate': '2023-01-20', 'unreleaseDate': '2023-01-20'}], 'estimatedResultsFirstSubmitDate': '2023-01-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D011305', 'term': 'Presbyopia'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012030', 'term': 'Refractive Errors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-13', 'studyFirstSubmitDate': '2016-07-12', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Visual Acuity Evaluation', 'timeFrame': '4 months', 'description': 'Corrected Distance Visual Acuity (CDVA)'}, {'measure': 'Visual Acuity Evaluation', 'timeFrame': '4 months', 'description': 'Uncorrected Near Visual Acuity (UNVA)'}, {'measure': 'Visual Acuity Evaluation', 'timeFrame': '4 months', 'description': 'Distance-Corrected Near Visual Acuity (DCNVA)'}, {'measure': 'Visual Acuity Evaluation', 'timeFrame': '4 months', 'description': 'Corrected Near Visual Acuity (CNVA)'}, {'measure': 'Visual Acuity Evaluation', 'timeFrame': '4 months', 'description': 'Uncorrected Intermediate Visual Acuity (UIVA)'}, {'measure': 'Visual Acuity Evaluation', 'timeFrame': '4 months', 'description': 'Distance-Corrected Intermediate Visual Acuity (DCIVA)'}, {'measure': 'Halos and Glare evaluation', 'timeFrame': '4 months', 'description': 'Onset of halos Onset of glare during night vision'}, {'measure': 'Contrast sensitivity', 'timeFrame': '4 months', 'description': 'Contrast sensitivity, at 3 meters, under photopic conditions and with the correction for distance, using YANG SMART (SIFI Medtech), with sine wave gradings (\'\'vistech")'}, {'measure': 'Reading Performance', 'timeFrame': '4 months', 'description': 'Reading Performance tested with Radner Reading Chart - Precision Vision:\n\nThe test will be performed from the largest to the smallest size of letters in two sessions:\n\n* Binocular, without the correction for distance, at 40 cm\n* Binocular, with the correction for distance, at 40 cm'}, {'measure': 'Defocus Curve', 'timeFrame': '4 months', 'description': 'Binocular defocus curves with step of 0.5 D (from +2.0 to -5.0 D) under photopic conditions.'}], 'primaryOutcomes': [{'measure': 'UDVA (Uncorrected Distance Visual Acuity)', 'timeFrame': '30 days', 'description': 'Visual acuity mesurement'}], 'secondaryOutcomes': [{'measure': 'Adverse Device Effects (ADE); Serious Adverse Device Effects (SADE); Unexpected Serious Adverse Device Effects (USADE); Adverse Events (AE); Serious Adverse Events (SAE).', 'timeFrame': '4 months', 'description': 'Safety assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Refractive lens exchange (RLE) or cataract surgery'], 'conditions': ['Cataract', 'Presbyopia']}, 'referencesModule': {'references': [{'pmid': '22553713', 'type': 'BACKGROUND', 'citation': 'Jiang T, Jiang J, Zhou Y, Zhao GQ, Li H, Zhao SY. Cataract surgery in aged patients: phacoemulsification or small-incision extracapsular cataract surgery. Int J Ophthalmol. 2011;4(5):513-8. doi: 10.3980/j.issn.2222-3959.2011.05.11. Epub 2011 Oct 18.'}, {'pmid': '18090888', 'type': 'BACKGROUND', 'citation': 'Packer M, Fine IH, Hoffman RS. Aspheric intraocular lens selection: the evolution of refractive cataract surgery. Curr Opin Ophthalmol. 2008 Jan;19(1):1-4. doi: 10.1097/ICU.0b013e3282f2d791. No abstract available.'}, {'pmid': '19643497', 'type': 'BACKGROUND', 'citation': 'Kohnen T, Klaproth OK, Buhren J. Effect of intraocular lens asphericity on quality of vision after cataract removal: an intraindividual comparison. Ophthalmology. 2009 Sep;116(9):1697-706. doi: 10.1016/j.ophtha.2009.03.052. Epub 2009 Jul 29.'}, {'pmid': '17166341', 'type': 'BACKGROUND', 'citation': 'Lehmann R, Waycaster C, Hileman K. A comparison of patient-reported outcomes from an apodized diffractive intraocular lens and a conventional monofocal intraocular lens. Curr Med Res Opin. 2006 Dec;22(12):2591-602. doi: 10.1185/030079906X158039.'}, {'pmid': '13129879', 'type': 'BACKGROUND', 'citation': 'Leyland M, Zinicola E. Multifocal versus monofocal intraocular lenses in cataract surgery: a systematic review. Ophthalmology. 2003 Sep;110(9):1789-98. doi: 10.1016/S0161-6420(03)00722-X.'}, {'pmid': '10724823', 'type': 'BACKGROUND', 'citation': 'Steinert RF. Visual outcomes with multifocal intraocular lenses. Curr Opin Ophthalmol. 2000 Feb;11(1):12-21. doi: 10.1097/00055735-200002000-00004.'}, {'pmid': '22018366', 'type': 'BACKGROUND', 'citation': 'Munoz G, Albarran-Diego C, Ferrer-Blasco T, Sakla HF, Garcia-Lazaro S. Visual function after bilateral implantation of a new zonal refractive aspheric multifocal intraocular lens. J Cataract Refract Surg. 2011 Nov;37(11):2043-52. doi: 10.1016/j.jcrs.2011.05.045.'}, {'pmid': '18786130', 'type': 'BACKGROUND', 'citation': 'Ucakhan OO, Ozkan M, Kanpolat A. Anterior chamber parameters measured by the Pentacam CES after uneventful phacoemulsification in normotensive eyes. Acta Ophthalmol. 2009 Aug;87(5):544-8. doi: 10.1111/j.1755-3768.2008.01305.x. Epub 2008 Sep 11.'}, {'pmid': '20506991', 'type': 'BACKGROUND', 'citation': 'Savini G, Olsen T, Carbonara C, Pazzaglia S, Barboni P, Carbonelli M, Hoffer KJ. Anterior chamber depth measurement in pseudophakic eyes: a comparison of Pentacam and ultrasound. J Refract Surg. 2010 May;26(5):341-7. doi: 10.3928/1081597X-20090617-02. Epub 2010 May 19.'}, {'pmid': '27113882', 'type': 'BACKGROUND', 'citation': 'Attia MS, Khoramnia R, Auffarth GU, Kirchner M, Holzer MP. Near and intermediate visual and reading performance of patients with a multifocal apodized diffractive intraocular lens using an electronic reading desk. J Cataract Refract Surg. 2016 Apr;42(4):582-90. doi: 10.1016/j.jcrs.2015.11.047.'}, {'pmid': '19969208', 'type': 'BACKGROUND', 'citation': 'Maxwell WA, Cionni RJ, Lehmann RP, Modi SS. Functional outcomes after bilateral implantation of apodized diffractive aspheric acrylic intraocular lenses with a +3.0 or +4.0 diopter addition power Randomized multicenter clinical study. J Cataract Refract Surg. 2009 Dec;35(12):2054-61. doi: 10.1016/j.jcrs.2009.06.041.'}]}, 'descriptionModule': {'briefSummary': 'This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.', 'detailedDescription': 'To evaluate if the positive results (to assure a good visual acuity at all distances and a good quality of life in terms of glasses independence and absence of undesired events), obtained experimentally using the IOL MINI WELL READY, can be confirmed in the practical surgical routine with a population belonging to different EU countries'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any gender and age above 18 years.\n* Refractive lens exchange (RLE) or cataract surgery.\n* Healthy corneas, not treated surgically.\n* Patients willing to have surgery in both eyes in a short period of time (within 2 weeks).\n* Patients request to receive the IOL MINI WELL READY implant\n\nExclusion Criteria:\n\n* Previous corneal surgery (i.e. pterygium, refractive surgery).\n* Eye diseases determining a probable postoperative visual acuity \\< 20/40.\n* Pseudoexfoliation.\n* Abnormal pupil size and position.\n* Use of contact lens 30 days before the preoperative visit.\n* Corneal warpage.\n* Predicted postoperative corneal astigmatism higher than 1 D.'}, 'identificationModule': {'nctId': 'NCT02838004', 'acronym': 'PSM15', 'briefTitle': 'Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'SIFI SpA'}, 'officialTitle': 'An Open Label, Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus', 'orgStudyIdInfo': {'id': 'PSM15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm receiving Mini WELL Ready IOL', 'description': 'IOL implantation for cataract', 'interventionNames': ['Device: IOL MINI WELL READY']}], 'interventions': [{'name': 'IOL MINI WELL READY', 'type': 'DEVICE', 'description': 'IOL MINI WELL READY', 'armGroupLabels': ['Single arm receiving Mini WELL Ready IOL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Prof.Dr. Gerd U. Auffarth', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'GERD U. AUFFARTH, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RUPRECHT KARLS UNIVERSITATS AUGENKLINIK HEIDELBERG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SIFI SpA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Opera CRO, a TIGERMED Group Company', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-01-20', 'type': 'RELEASE'}, {'date': '2023-01-20', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'SIFI SpA'}}}}