Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 11:27 PM
Study NCT ID:
NCT06075459
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2023-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-10-04', 'studyFirstSubmitQcDate': '2023-10-04', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL.', 'timeFrame': '21-24 months post operation', 'description': 'Performance of the IOL will be evaluated by assessing the defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.'}], 'secondaryOutcomes': [{'measure': 'The second aim of this study is to evaluate the patient satisfaction post-operation.', 'timeFrame': '21-24 months post operation', 'description': 'Patient satisfaction will be evaluated by using Quality of Life (VH14) and satisfaction Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cataract', 'IOL', 'Hanita Lenses'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This clinical study will assess the safety and performance of Intensity SL IOL, 1 year post operation.\n\nThe study will also evaluate the patient satisfaction of the implanted patients.', 'detailedDescription': "Study Design:\n\nThis study is an ambispective, single arm single center, open label study.\n\nStudy Objectives:\n\nThe aim of this study is to evaluate performance of Hanita Lenses Intensity SL IOL. The primary aim of this study is to evaluate the binocular defocus Curve and visual acuity for far, intermediate and near distance after Intensity SL IOL implantation.\n\nThe second aim of this study is to evaluate the patient satisfaction 12 to 24 months post-operation.\n\nStudy population:\n\nMen and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.\n\nEnrollment:\n\nThe study will encompass a total of 60 eligible subjects implanted bilaterally (120 eyes) in total who will complete the protocol follow-up schedule.\n\nDuration of Subject participation:\n\nDuration of Subject participation is at most one month Completion of active enrolment is anticipated to last approximately 6 months. The primary aim will be finally evaluated when the last study subject has been recruited.\n\nVisits \\& Procedures Patients participating in the trial will attend a total of one visit (1 year follow up visit).\n\nSubjects will be selected from the physician's usual subjects' practice. All subjects meeting the inclusion criteria and having signed the Informed Consent Form will be evaluated by the Investigator according to the study protocol.\n\n1 year follow up visit: Pre-operation Visit: performed to check inclusion criteria, and to sign the informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Implanted bilaterally using Hanita Intensity SL IOL\n* 12 to 24 months post implantation\n* Signed informed consent\n\nExclusion Criteria:\n\n• Patients with any other pre-implantation and post implantation eye disease or condition that might affect the safety and efficacy evaluation.'}, 'identificationModule': {'nctId': 'NCT06075459', 'acronym': 'Post-op', 'briefTitle': 'Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanita Lenses'}, 'officialTitle': 'Post Marketing Clinical Evaluation Assessing the Visual Performance of Hanita Lenses "Intensity SL" Intraocular Lens', 'orgStudyIdInfo': {'id': 'HTF-PM-AR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Implanted patients with Intensity IOLs, 12-24 months previously', 'description': 'Men and women who had implantation on both eyes using Hanita Lenses SeeLens SL IOL, for 12 to 24 months post operation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1655 4 A', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Dr. Nano Eye Clinic', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'German Bianchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Nano Eye Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanita Lenses', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}