Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-29 @ 4:24 PM
Study NCT ID:
NCT04801992
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2021-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Refraction', 'timeFrame': '26 months'}, {'measure': 'Binocular Defocus Curve', 'timeFrame': '26 months', 'description': 'Binocular Defocus Curve (+2.0 D to -4.0 D in 0.5 D increments)'}, {'measure': 'UDVA', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Uncorrected Distance Visual Acuity (UDVA) at 4m'}, {'measure': 'CDVA', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Corrected Distance Visual Acuity (CDVA) at 4m'}, {'measure': 'UIVA at 100 cm', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Uncorrected Intermediate Visual Acuity at 100 cm (100% and 10% contrast)'}, {'measure': 'DCIVA at 100 cm', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Distance Corrected Intermediate Visual at 100 cm (100% and 10% contrast)'}, {'measure': 'UIVA at 60 cm', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Uncorrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)'}, {'measure': 'DCIVA at 60 cm', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Distance Corrected Intermediate Visual Acuity at 60 cm (100% and 10% contrast)'}, {'measure': 'UNVA', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Uncorrected Near Visual Acuity at 40cm (100% contrast)'}, {'measure': 'DCNVA', 'timeFrame': '26 months', 'description': 'Monocular and Binocular Distance Corrected Near Visual Acuity at 40cm (100% contrast)'}, {'measure': 'Contrast Sensitivity', 'timeFrame': '26 months', 'description': 'Binocular Contrast Sensitivity with correction for distance'}, {'measure': 'Reading Performance', 'timeFrame': '26 months', 'description': 'Binocular Reading Performance with and without correction for distance'}, {'measure': 'VR-11R', 'timeFrame': '26 months', 'description': 'Visual Function -11R Questionnaire from 4 (without difficulties) to 0 (performance impossible due to difficulties)'}], 'secondaryOutcomes': [{'measure': 'Postoperative Complications Rate of postoperative complication', 'timeFrame': '26 months'}, {'measure': 'Subjective Posterior Capsule Opacification', 'timeFrame': '20-26 months', 'description': 'Subjective assessment through slit lamp'}, {'measure': 'Posterior Capsulotomy', 'timeFrame': '26 months'}, {'measure': 'Adverse Events including SSIs', 'timeFrame': '26 months'}, {'measure': 'Device Deficiencies', 'timeFrame': '26 months', 'description': 'Descriptive assessment'}, {'measure': 'Photic Phenomena Assessment', 'timeFrame': '26 months', 'description': 'Using the Halo and Glare Simulator software'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract surgery', 'Extended Depth-of-Focus (EDOF)', 'Intraocular Lens (IOL)', 'Presbyiopa correction'], 'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '22553713', 'type': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': '16687454', 'type': 'RESULT', 'citation': 'Becker KA, Martin M, Rabsilber TM, Entz BB, Reuland AJ, Auffarth GU. Prospective, non-randomised, long term clinical evaluation of a foldable hydrophilic single piece intraocular lens: results of the Centerflex FDA study. Br J Ophthalmol. 2006 Aug;90(8):971-4. doi: 10.1136/bjo.2006.092437. Epub 2006 May 10.'}, {'pmid': '17166341', 'type': 'RESULT', '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': 'RESULT', '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': 'RESULT', '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': '16931257', 'type': 'RESULT', 'citation': 'Blaylock JF, Si Z, Vickers C. Visual and refractive status at different focal distances after implantation of the ReSTOR multifocal intraocular lens. J Cataract Refract Surg. 2006 Sep;32(9):1464-73. doi: 10.1016/j.jcrs.2006.04.011.'}]}, 'descriptionModule': {'briefSummary': 'The study objective is to evaluate the visual performance of MINI WELL Ready at 24 months following the second eye implant. The objectives of safety are to evaluate the rate of Secondary Surgical Interventions related to the optical properties of the IOL for first and second operative eye separately at 24 months and the rate of visual disturbances and distortions as reported by the subjects as detected by using the Halo \\& Glare Simulator.', 'detailedDescription': 'The present post-.market follow-up study (PSM8 sub-study) is an ancillary study of the PSM8 post market clinical trial (NCT02740010)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects affected by cataract that fulfill eligibility criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Previous enrolment in the PSM8 study in the period from March, 1st 2014 to March, 31st 2016 with the following:\n\n* Any gender and age above 18 years.\n* Cataract or Refractive Lens Exchange (RLE) surgery; will be included patients submitted to conventional phacoemulsification as to femtolaser procedure; no specification regarding corneal incision size and position.\n* Symmetrical preoperative keratometric astigmatism \\< 1.00 D.\n* Healthy corneas, not surgically treated\n\nExclusion Criteria:\n\n* Previous corneal surgery (i.e. pterygium, refractive surgery).\n* Eye diseases with visual acuity \\< 20/32.\n* Pseudoexfoliation.\n* Abnormal pupil size and position.\n* Use of contact lens 30 days before the preoperative visit.\n* Corneal warpage.'}, 'identificationModule': {'nctId': 'NCT04801992', 'briefTitle': 'Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After the Second Eye Implant', 'organization': {'class': 'INDUSTRY', 'fullName': 'SIFI SpA'}, 'officialTitle': 'Retrospective, Observational, Monocenter And Single-Arm Trial Following Subjects Bilaterally Implanted With Mini Well Ready For 2 Years After The Second Eye Implant', 'orgStudyIdInfo': {'id': 'PSM8 Sub-study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MINI WELL Ready (SIFI SpA, Italy)', 'description': 'Extended depth of focus intraocular lens implantation', 'interventionNames': ['Device: MINI WELL Ready (SIFI SpA, Italy)']}], 'interventions': [{'name': 'MINI WELL Ready (SIFI SpA, Italy)', 'type': 'DEVICE', 'description': 'Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients.', 'armGroupLabels': ['MINI WELL Ready (SIFI SpA, Italy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70121', 'city': 'Bari', 'country': 'Italy', 'facility': 'U.O. Oftalmologia I Dipartimento di Scienze Mediche di Base, Neuroscienze e Organi di Senso Università degli Studi di Bari "Aldo Moro"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SIFI SpA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Opera CRO, a TIGERMED Group Company', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}