Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04967612
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2021-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Visual Perception After Virtual Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-21', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Corrected distance visual acuity', 'timeFrame': 'during the intervention', 'description': 'Evaluate visual acuity at distance following virtual implantation of diffractive optical lens designs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Evaluation of visual perception through diffractive optical lens designs by virtual implantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects between and including 18 and 50 years of age;\n* Healthy eyes;\n* Dominant eye with a monocular CDVA ≥1.0 decimal (≤ 0.0 logMAR) without cycloplegia;\n* Subject who has been informed of the consequences and constraints of the protocol and who has given his/her written informed consent;\n* Negative COVID19 screening test prior to every trial visit.\n\nExclusion Criteria:\n\n* Subjects of less than 18 or more than 50 years of age;\n* Monocular CDVA of dominant eye \\< 1.0 decimal (\\> 0.0 logMAR) without cycloplegia;\n* Subject unable to comply with the study protocol or likely to be non-cooperative during the study;\n* Subject whose freedom is impaired by administrative or legal issues, or adult persons under legal protection or unable to give an informed consent;\n* Pseudophakic subjects;\n* Subjects, who are unable to fixate for a longer time, e.g. strabismus, nystagmus;\n* Pathologic miosis;\n* Intake of drugs affecting vision;\n* Participation in another biomedical study in parallel, if it affects vision or if interactions with cycloplegia exist;\n* Intolerance to or contraindication to cycloplegia, e.g. due to narrow angle of the anterior ocular chamber;\n* Hyperopes with more than +6 D refraction.'}, 'identificationModule': {'nctId': 'NCT04967612', 'briefTitle': 'Visual Perception After Virtual Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carl Zeiss Meditec AG'}, 'officialTitle': 'Evaluation of Visual Perception Through Diffractive Optical Lens Designs by Virtual Implantation.', 'orgStudyIdInfo': {'id': 'PJV2002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Virtual implantation of diffractive optical lens design A', 'interventionNames': ['Other: Virtual implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual implantation of diffractive optical lens design B', 'interventionNames': ['Other: Virtual implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual implantation of diffractive optical lens design C', 'interventionNames': ['Other: Virtual implantation']}], 'interventions': [{'name': 'Virtual implantation', 'type': 'OTHER', 'description': 'Temporary placement of virtual optical lens in the crystalline lens plane.', 'armGroupLabels': ['Virtual implantation of diffractive optical lens design A', 'Virtual implantation of diffractive optical lens design B', 'Virtual implantation of diffractive optical lens design C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07745', 'city': 'Jena', 'country': 'Germany', 'facility': 'JenVis Research', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'W Sickenberger, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'JenVis Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carl Zeiss Meditec AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}