Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT02903927
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2016-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-13', 'lastUpdatePostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uncorrected distance visual acuity (UCVA) (monocular)', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Catartact']}, 'descriptionModule': {'briefSummary': 'The main objective of the clinical study is to evaluate the performance of the CT LUCIA 601 PY for the monocular uncorrected distance visual acuity and compare it to the reference monofocal IOL Acrysof IQ SN60WF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient informed of the consequences and constraints of the protocol and who has given his/her written informed consent;\n* Patients of any gender, aged 50 to 90 years;\n* Senile cataract in at least 1 eye;\n* Assured follow-up examinations;\n* Healthy eyes besides clinically significant cataract\n* Biometry measurement/cataract density compatible with the IOLMaster evaluation.\n\nPost-operative inclusion criteria:\n\n* IOL implanted in the capsular bag;\n* The IOL model (CT LUCIA 601PY or Acrysof IQ SN60WF) has been implanted;\n* No intraoperative complications; no damaged capsular bag, no intraocular hemorrhage; no can opener rhexis.\n\nExclusion Criteria:\n\n* • Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial;\n\n * Patients whose freedom is impaired by administrative or legal order;\n * Current participation in another drug or device investigation;\n * Allergy to heparin\n * Monophthalmic patient\n * Ocular disorders, other than cataract, that could potentially cause future acuity loss to a level of 0.20 logMAR (best-corrected) or worse the operated eye\n * Any anterior segment pathology that could significantly affect outcomes (e.g. chronic uveitis, iritis, corneal dystrophy, etc.)\n * Diabetic retinopathy\n * Traumatic cataract\n * Aniridia\n * Microphthalmus\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 follow-up\n * Previous intraocular and corneal surgery\n * Expected postop. astigmatism greater than 1 D\n * Any type of corneal disorder\n * Dementia\n * Diabetes mellitus\n * Pseudoexfoliation syndrome (PXF)\n * Glaucoma or IOP higher than 24mmHg under ocular hypertension treatment\n * Any other pathology or condition presenting, according to the investigator opinion, a risk for the patient'}, 'identificationModule': {'nctId': 'NCT02903927', 'acronym': 'LUCIOL', 'briefTitle': 'Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'Prospective Comparative Randomized Clinical Trial to Evaluate the Visual Performance of Two Monofocal Intraocular Lenses', 'orgStudyIdInfo': {'id': 'CT LUCIA 601PY BER 401-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT LUCIA', 'interventionNames': ['Device: Implantation of CT LUCIA IOL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acrysof IQ Sn60WF', 'interventionNames': ['Device: Implantation of Acrysof IQ SN60WF IOL']}], 'interventions': [{'name': 'Implantation of CT LUCIA IOL', 'type': 'DEVICE', 'armGroupLabels': ['CT LUCIA']}, {'name': 'Implantation of Acrysof IQ SN60WF IOL', 'type': 'DEVICE', 'armGroupLabels': ['Acrysof IQ Sn60WF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}