Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04907318
Status:
COMPLETED
Last Update Posted:
2021-06-02
First Post:
2021-05-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between a Toric Monofocal and Multifocal Intraocular Lens
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': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2016-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-28', 'studyFirstSubmitDate': '2021-05-25', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To observe the rotational stability of the implant', 'timeFrame': '6 Months', 'description': 'Observation of rotational stability of the implant'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': '6 Months', 'description': 'To assess the visual acuities with and without correction and the best refraction to assess the benefit of the implants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IOL', 'Toric', 'Multifocal'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to observe the rotational stability of the implant 30 minutes, one day, 6 weeks, 6 months and 12 months after the implant surgery. In addition, the refraction will be measured as it is directly affected in the event of postoperative rotation. The correlation between postoperative rotation and the following parameters will be determined: PEXS, white-to-white, age, axial length, anterior chamber depth. Visual acuities with and without correction and the best refraction to assess the benefit of the implants will also be investigated.', 'detailedDescription': "This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher. They had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.\n\nInclusion criteria for research participants.\n\n* Cataract (with or without presbyopia)\n* No pre-existing ocular pathology or history of ocular surgery\n* No phacodonesis\n\nPEX patients (pseudoexfoliation syndrome) can be included. Exclusion criteria for research participants. To ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.\n\nIn particular the patients with the following pathologies will be excluded:\n\n* Irregular astigmatism.\n* Cases of uncontrolled glaucoma.\n* Intraocular inflammation.\n* Narrow anterior chambers (2.5 mm).\n* Amblyopia with potential visual acuity less than 5/10.\n* Any corneal pathology potentially affecting topography (e.g., keratoconus).\n* Patients with a history of corneal surgery (especially refractive surgery).\n* Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.\n* Patients with a history of ocular trauma.\n* Pathological miosis.\n* Patients with zonular laxity.\n* Patients suffering from chronic uveitis.\n* Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.\n\n 3 - Adopted observation or investigation method This study involves the collection of data in patient records that fall within the normal framework of cataract surgery.\n\nThe demographic and clinical data collected will be the yeat of birth and patient's gender, including ocular or general comorbidities (such as diabetes or rheumatoid illnesses) justifying the visual acuity performance.\n\nThe preoperative data collected will be: visual acuity, intraocular pressure, cell density of the corneal endothelium, axial length and corneal power in both axes (data required to routinely calculate the power of the implant and entered into the record to understand any postoperative refractive errors).\n\nThe intraoperative data will be the power of the implant and any complications, if applicable.\n\nThe postoperative data will be data collected during the standard postoperative follow-up performed at 30 minutes, 1 day, one week, 6 weeks, 6 months and 1 year, with patient questioning, slit lamp observation with implant position, measuring intraocular pressure, determining the best refraction and measuring visual acuity with and without correction (near, far and intermediate vision).\n\n4 - Origin and nature of collected personal data Reason for using this data Observations will be obtained by the doctor from patient records. Clinical data will be used to link potential poor postoperative visual acuity and a comorbidity.\n\nRefractive data will help determine the implant stability in the eye in terms of its depth, i.e. in the sagittal plane, and its rotational stability, i.e. coronal plane stability.\n\nChanges will determine its stability in the coronal plane around the visual axis.\n\nThe intraocular pressure analysis and slit lamp examination will help determine the eye inflammatory status before and after surgery.\n\nThe record of postoperative keratometry values will help determine whether the error or a refractive change caused by the corneal instability or by the change in the implant position."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study will include approximately 90 eyes of patients (adults) receiving conventional cataract surgery having a preoperative corneal astigmatism of 1.0 D or higher and had been implanted with the Ankoris or T-Flex or FineVision toric implant (about 30/30 and20). So that the groups are comparable, the inclusion and exclusion criteria will be those applicable to a multifocal implant.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cataract (with or without presbyopia)\n* No pre-existing ocular pathology or history of ocular surgery\n* No phacodonesis\n\nPEX patients (pseudoexfoliation syndrome) can be included.\n\nExclusion Criteria:\n\nTo ensure equivalence of the two comparable groups, the patients with potential postoperative visual acuity less than 5/10, particularly due to an insufficient retinal function or poor corneal condition will be excluded.\n\nIn particular the patients with the following pathologies will be excluded:\n\n* Irregular astigmatism.\n* Cases of uncontrolled glaucoma.\n* Intraocular inflammation.\n* Narrow anterior chambers (2.5 mm).\n* Amblyopia with potential visual acuity less than 5/10.\n* Any corneal pathology potentially affecting topography (e.g., keratoconus).\n* Patients with a history of corneal surgery (especially refractive surgery).\n* Patients with diagnosed degenerative visual disorders (e.g., macular degeneration, diabetic retinopathy or other retina diseases or surgery) with known negative impact on visual function possibly leading to visual acuity levels below 0.5.\n* Patients with a history of ocular trauma.\n* Pathological miosis.\n* Patients with zonular laxity.\n* Patients suffering from chronic uveitis.\n* Patients with monophthalmia. Capsule rupture, intraocular haemorrhage, excessive loss of vitreous, vitreous flare, soft capsules during cataract surgery are also exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT04907318', 'briefTitle': 'Comparison Between a Toric Monofocal and Multifocal Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beaver-Visitec International, Inc.'}, 'officialTitle': 'Retrospective Study Analysing the Results of Toric and Toric Multifocal Intraocular Lens Implantation During Cataract Surgery.', 'orgStudyIdInfo': {'id': 'PHY PODT-POD FT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ANKORIS', 'description': 'Cataract surgery performed with POD26PAYT', 'interventionNames': ['Device: Cataract surgery']}, {'label': 'FINEVISION TORIC', 'description': 'Cataract surgery performed with POD26PAYFT', 'interventionNames': ['Device: Cataract surgery']}], 'interventions': [{'name': 'Cataract surgery', 'type': 'DEVICE', 'armGroupLabels': ['ANKORIS', 'FINEVISION TORIC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3930', 'city': 'Visp', 'country': 'Switzerland', 'facility': 'Vista Alpina Eye Center', 'geoPoint': {'lat': 46.2937, 'lon': 7.88149}}], 'overallOfficials': [{'name': 'Kristof Vandekerckhove, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vista Alpina Eye Cente, Visp, Switzerland, 3930'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beaver-Visitec International, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}