Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT05194150
Status:
UNKNOWN
Last Update Posted:
2022-01-18
First Post:
2022-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Two Intraocular Lenses With Extended Depth of Vision
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2024-01-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity at intermediate distance', 'timeFrame': '24 months', 'description': 'The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs'}], 'secondaryOutcomes': [{'measure': 'Visual acuity at far distance', 'timeFrame': '24 months', 'description': 'The visual acuity at the far distance will be measured using ETDRS charts at a distance of 4 metres and compared between the two different IOLs'}, {'measure': 'Visual acuity at near distance', 'timeFrame': '24 months', 'description': 'The visual acuity at the near distance will be measured using ETDRS charts at a distance of 40 centimetres and compared between the two different IOLs'}, {'measure': 'Visual acuity in the defocus curve', 'timeFrame': '24 months', 'description': 'The visual acuity in the defocus curve will be measured using ETDRS charts at 4 metres with the patient wearing glasses in the power range of -3.5 to +1.0 diopters (presented in 0.5 dioptre steps) and will be compared between the two IOLs'}, {'measure': 'Halometry', 'timeFrame': '24 months', 'description': 'The size of the halos depicted in degrees will be assessed using the aston halometer and will be compared between the two IOLs'}, {'measure': 'Contrast sensitivity', 'timeFrame': '24 months', 'description': 'Contast sensitvity will be measured using the Optec Vision tester and will be compared between the two IOLs'}, {'measure': 'Reading speed', 'timeFrame': '24 months', 'description': 'Reading speed will be assessed with teh Salzburg Reading Desk and will be compared between the two different IOLs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract', 'Cataract surgery', 'enhanced depth of focus intraocular lens'], 'conditions': ['Cataract Senile']}, 'descriptionModule': {'briefSummary': 'Comparison of the capsular bag performance of two extended depth of vision (EDOF) intraocular lenses (IOLs), the Rayone EMV and the Alcon Acrysof IQ Vivity, in a mini-monovision setting', 'detailedDescription': 'Spectacle independence is a rising aim in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result.\n\nThe option commonly used to achieve spectacle independence in all distances are multifocal intraocular lenses. One concept of multifocality is the trifocal lens. This lens provides good vision in three focal distances: far, intermediate, and near. However, one potential disadvantage of trifocal IOLs is slightly poorer near vision with need for reading gasses for prolonged fine near work and loss of contrast sensitivity in the intermediate distance.\n\nA better intermediate performance concerning contrast vision compared to trifocal IOLs can be reached using enhanced depth of focus (EDOF) lenses. These IOLs have an extended far focus area, which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The disadvantage compared to monofocal lenses in all of these technologies is the potentially worse contrast sensitivity as well as dysphotopsia.\n\nA new monofocal non-diffractive lens with an extended depth of vision (Rayone EMV) promises an increased range of functional vision and less dysphotopsias. Especially in a monovision setting, where the dominant eye is set for emmetropia and the other eye for low myopia is believe dto be a promising concept for spectacle independence.\n\nHence, the aim of this study is to compare a new monofocal IOL wit a non-diffractive extended depth of vision (Rayone EMV) with an already established non-diffractive EDOF IOL (Alcon Acrysof IQ Vivity) in a mini-monovision setting.\n\n96 eyes of 48 patients will be included into this study. After randomization, each patient will either receive the Rayone EMV or the Alcon Acrysof IQ Vivity in both eyes. Follow-up visits will be 2 weeks and 3 months after surgery. During these visits a slitlamp examination, measurement of the intraocular pressure, visual acuity assessment, pupil size measurement, determination of the defocus curve, contrast sensitivity measurements, reading speed detection, and a flaremeter measurement will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age-related bilateral cataract\n* age 21 or older\n* visual acuity \\> 0.05\n* axial length: 22.0 - 26.0 mm\n* normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant\n* written informed consent prior to surgery\n\nExclusion Criteria:\n\n* active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)\n* relevant othe rophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)\n* corneal decompensation or corneal endothelial cell insufficiency\n* previous ocular surgery or trauma\n* persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)\n* corneal astigmatism \\> 1 dpt.\n* retinopathies'}, 'identificationModule': {'nctId': 'NCT05194150', 'briefTitle': 'Performance of Two Intraocular Lenses With Extended Depth of Vision', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision', 'orgStudyIdInfo': {'id': 'Rayner Performance'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rayone EMV', 'description': 'Patient will receive the non-diffractive monofocal IOL during cataract surgery', 'interventionNames': ['Device: non-diffractive monofocal IOL']}, {'type': 'EXPERIMENTAL', 'label': 'Acrysof IQ Vivity', 'description': 'Patient will receive the standard EDOF IOL during cataract surgery', 'interventionNames': ['Device: standard EDOF IOL']}], 'interventions': [{'name': 'non-diffractive monofocal IOL', 'type': 'DEVICE', 'description': 'Rayone EMV', 'armGroupLabels': ['Rayone EMV']}, {'name': 'standard EDOF IOL', 'type': 'DEVICE', 'description': 'Acrysof IQ Vivity', 'armGroupLabels': ['Acrysof IQ Vivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Johannes Zeilinger, MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}, {'name': 'Natascha Bayer, MSc', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}], 'facility': 'Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Johannes Zeilinger, MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}, {'name': 'Natascha Bayer, MSc', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}], 'overallOfficials': [{'name': 'Oliver Findl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vienna Institute for Research in Ocular Surgery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Prim. Prof. Dr. Oliver Findl, MBA', 'investigatorAffiliation': 'Vienna Institute for Research in Ocular Surgery'}}}}