Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-24 @ 2:18 PM
Study NCT ID:
NCT06345820
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses
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': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Monocular intermediate visual acuity', 'timeFrame': '24 months', 'description': 'Monocular intermediate visual acuity at 66 cm will be measured using ETDRS charts'}], 'secondaryOutcomes': [{'measure': 'Monocular distance visual acuity', 'timeFrame': '24 months', 'description': 'Monocular distance visual acuity at 4 meters will be measured using ETDRS charts'}, {'measure': 'Monocular near visual acuity', 'timeFrame': '24 months', 'description': 'Monocular near visual acuity at 40 cm will be measured using ETDRS charts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract', 'Cataract surgery', 'Intraocular lens'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'Comparison of the clinical performance of two enhanced monofocal IOLs with similar design.', 'detailedDescription': 'In modern cataract surgery the aim of the procedure is not just the restoration of vision but to also achieve some spectacle independence. Bilateral implantation of monofocal intraocular lenses (IOL) aiming for emmetropia lead to high patient satisfaction levels in distance vision but leave patients dependent on spectacles in intermediate and near vision tasks.\n\nTo achieve high levels of spectacle independence the most commonly used option are multifocal intraocular lenses (MIOL). These MIOLs use either a refractive or diffractive optical design, a combination of both or segmented asymmetric optics. Usually, the characteristic diffractive ring patterns are incorporated on the posterior surface of an IOL, whereas the anterior lens surface remains purely refractive. However, a portion of patients experience problems with positive dysphotopsia symptoms such as halos and glare. Other potentially negative aspects of MIOLs are pupil size dependency and loss of light energy to higher order diffraction which can lead to reduced contrast sensitivity. In clinical studies diffractive lenses resulted in a better outcome in terms of optical quality, better contrast sensitivity and positive dysphotopsia phenomena than refractive multifocal lenses.\n\nA newer concept of IOLs are non-diffractive enhanced range of vision (EROV) IOLs, sometimes also referred to as EDOF IOLs. The EROV IOLs with the least compromise concerning quality of vision are the group of so called enhanced monofocal IOL, also sometime referred to as monofocal plus IOL. These IOLs should result in better intermediate vison and provide contrast sensitivity and dysphotopsia results comparable to standard monofocal IOLs. These IOLs may be more adequate to meet the expectations of many presbyopic cataract patients, who were used to have a good distance vision and who were wearing spectacles when performing near vision tasks before surgery.\n\nThe aim of this study is to compare the clinical performance of a newer enhanced monofocal IOL (Evolux) with a standard enhanced monofocal IOL, the Tecnis Eyhance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral cataract\n* Age 21 or older\n* Visual acuity \\> 0.05\n* Axial length: 22.00-26.00mm\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* Availability, willingness and sufficient cognitive awareness to comply with examination procedures\n\nExclusion Criteria:\n\n* Active ocular disease (e.g. chronic uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)\n* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), Intraoperative Floppy Iris Syndrome (IFIS)\n* Corneal decompensation or corneal endothelial cell insufficiency\n* Amblyopia\n* Previous ocular surgery or trauma\n* Persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)\n* Astigmatism with the need for a toric IOL'}, 'identificationModule': {'nctId': 'NCT06345820', 'briefTitle': 'Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses', 'organization': {'class': 'OTHER', 'fullName': 'Vienna Institute for Research in Ocular Surgery'}, 'officialTitle': 'Intermediate Visual Acuity Comparison of Two Non-diffractive Enhanced Monofocal Intraocular Lenses', 'orgStudyIdInfo': {'id': 'Evolux'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evolux', 'description': 'Patient will receive the Enova IOL during cataract surgery', 'interventionNames': ['Device: Evolux']}, {'type': 'EXPERIMENTAL', 'label': 'Tecnis Eyhance', 'description': 'Patient will receive the Tecnis Ehance IOL during cataract surgery', 'interventionNames': ['Device: Tecnis Eyhance']}], 'interventions': [{'name': 'Evolux', 'type': 'DEVICE', 'description': 'Evolux, enhanced monofocal IOL', 'armGroupLabels': ['Evolux']}, {'name': 'Tecnis Eyhance', 'type': 'DEVICE', 'description': 'Tecnis Eyhance, enhanced monofocal IOL', 'armGroupLabels': ['Tecnis Eyhance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1140', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Andreas Rotter, MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}, {'name': 'Manuel Ruiss, 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': 'Andreas Rotter, MD', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}, {'name': 'Manuel Ruiss, MSc', 'role': 'CONTACT', 'email': 'office@viros.at', 'phone': '01 91021', 'phoneExt': '57564'}], 'overallOfficials': [{'name': 'Oliver Findl, Prim. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Krankenhaus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}