Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-11 @ 10:28 PM
Study NCT ID:
NCT03172351
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2017-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EDoF IOLs vs Monofocal IOL
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2017-05-24', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Defocus curve measurement', 'timeFrame': '1 month'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'referencesModule': {'references': [{'pmid': '32915276', 'type': 'DERIVED', 'citation': 'Reinhard T, Maier P, Bohringer D, Bertelmann E, Brockmann T, Kiraly L, Salom D, Piovella M, Colonval S, Mendicute J. Comparison of two extended depth of focus intraocular lenses with a monofocal lens: a multi-centre randomised trial. Graefes Arch Clin Exp Ophthalmol. 2021 Feb;259(2):431-442. doi: 10.1007/s00417-020-04868-5. Epub 2020 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'prospective, comparative (3 arms), randomized, multicentric clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient informed of the consequences and constraints of the Clinical Investigational Plan and who has given his/her written informed consent;\n* Patients of any gender, aged 50 to 80 years;\n* Assured follow-up examinations;\n* clinically significant bilateral cataract;\n\nExclusion Criteria:\n\n* Patients unable to meet the limitations of the Clinical Investigational Plan or likely of non-cooperation during the trial;\n* Patients whose freedom is impaired by administrative or legal order;\n* Current participation in another drug or device investigation;\n* Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (corrected) or worse in either eye\n* Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)\n* Pseudoexfoliations syndrome\n* Pathologic miosis or Pharmacotherapy with miotic agent\n* Keratoconus\n* Chronic or recurrent uveitis\n* Diabetic retinopathy\n* Uncontrolled glaucoma and or IOP\\>24mmHg\n* Choroidal hemorrhage,\n* All kind of infections (acute ocular disease, external/internal infection, systemic infection)\n* Traumatic cataract\n* Aniridia\n* Microphthalmia\n* Amblyopia\n* Degenerative visual disorders (e.g. macular degeneration, optic nerve atrophy, or retinal disorders)\n* Patient expected to require retinal laser treatment before the end of the 4-6 months follow-up\n* Previous intraocular and corneal surgery\n* Expected postop. astigmatism greater than 1 D\n* Any type of corneal disorder\n* Systemic or ocular pharmacotherapy, which can impact the visual acuity,\n* Former, current or foreseeable application of Tamsulosin or Silodosin (e.g. Flomax, Flomaxtra, Rapflo) ) which potentially can cause the floppy iris syndrome, insufficient dilation, or missing of appropriate iris structures which can compromise the standard procedure according to the investigator's opinion\n* Patients who are unable to fixate for longer time (e.g. strabismus, nystagmus)\n* Dementia\n* pregnancy or lactation period for female patients"}, 'identificationModule': {'nctId': 'NCT03172351', 'briefTitle': 'EDoF IOLs vs Monofocal IOL', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'Prospective Randomized Clinical Trial Comparing Extended Depth of Focus Intraocular Lenses With a Monofocal Intraocular Lens', 'orgStudyIdInfo': {'id': 'AT LARA 829MP BER-401-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EDoF1', 'interventionNames': ['Device: Monofocal', 'Device: EDoF2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Monofocal', 'interventionNames': ['Device: EDoF1', 'Device: EDoF2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EDoF2', 'interventionNames': ['Device: EDoF1', 'Device: Monofocal']}], 'interventions': [{'name': 'EDoF1', 'type': 'DEVICE', 'description': 'extended depth of focus IOL - EDoF1', 'armGroupLabels': ['EDoF2', 'Monofocal']}, {'name': 'Monofocal', 'type': 'DEVICE', 'description': 'Monofocal IOL', 'armGroupLabels': ['EDoF1', 'EDoF2']}, {'name': 'EDoF2', 'type': 'DEVICE', 'description': 'Comparison EDoF2 IOL', 'armGroupLabels': ['EDoF1', 'Monofocal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Zeiss Study Site', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}