Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06294405
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraocular Lens Implant Registry Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019654', 'term': 'Lens Implantation, Intraocular'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2029-02-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional results with different Intraocular lenses', 'timeFrame': '6 months', 'description': 'Visual acuity with different intraocular lenses is determined.'}, {'measure': 'Contrast sestivitiy with different Intraocular lenses', 'timeFrame': '6 months', 'description': 'Contrast sensitivity with different intraocular lenses is determined.'}, {'measure': 'Anatomical results.', 'timeFrame': '6 months', 'description': 'Anatomical results with different intraocular lenses are determined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraocular Lens Complication', 'Intraocular Lens Rotation', 'Intraocular Lens Associated Postoperative Inflammation', 'Lens Opacities']}, 'descriptionModule': {'briefSummary': 'The goal of this registry study is to optimize the results with intraocular lens implants used in cataract surgery.', 'detailedDescription': 'A variety of intraocular lens implants are available for patients undergoing cataract surgery and new technologies are continuously being developed in this field.\n\nIn the planned monocentric retro- and prospective clinical study, a database to optimize outcomes with modern intraocular lens implants will be established to further improve anatomical and functional outcomes.\n\nPatients treated with an intraocular lens implant will be included. The retrospective evaluation of data includes data routinely collected prior to study inclusion (preoperative, intraoperative, postoperative up to the 1st study visit). Prospectively, refraction, visual acuity, examination findings, intraocular pressure and complications are recorded 1-6 months postoperatively. Depending on the type of IOL, results of further non-invasive measurements are also recorded. Optional follow-up visits with the aforementioned examinations are possible up to 10 years postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who receive an intraocular lens are offered to participate in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTreatment with an intraocular lens implant 18 years of age or older Patient consent Full legal capacity\n\nExclusion Criteria:\n\nDementia Pregnancy Breastfeeding'}, 'identificationModule': {'nctId': 'NCT06294405', 'briefTitle': 'Intraocular Lens Implant Registry Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Augsburg'}, 'officialTitle': 'Development of a Database to Optimize the Results With Intraocular Lens Implants', 'orgStudyIdInfo': {'id': '24-0010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intraocular lens Implantation', 'type': 'DEVICE', 'description': 'Intraocular lenses are implanted during cataract surgery to replace the human crystalline lens.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Augsburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Isabella Baur, MD', 'role': 'CONTACT'}], 'facility': 'University Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}], 'centralContacts': [{'name': 'Isabella Baur, MD', 'role': 'CONTACT', 'email': 'Isabella.Baur@uk-augsburg.de', 'phone': '0049821 400-2566'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophthalmologist', 'investigatorFullName': 'Dr. med.Isabella Baur', 'investigatorAffiliation': 'University Hospital Augsburg'}}}}