Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2025-12-27 @ 9:30 PM
Study NCT ID:
NCT06364761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of Intermediate Vision After BIL Cataract Surgery
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': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intermediate vision', 'timeFrame': 'During the only hospital visit required in the study, between april and december 2024', 'description': 'uncorrected and distance corrected intermediate vision at 66cm in LogMAR'}], 'secondaryOutcomes': [{'measure': 'Near vision', 'timeFrame': 'During the only hospital visit required in the study, between april and december 2024', 'description': 'uncorrected and distance corrected intermediate vision at 40cm in LogMAR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bag in lens', 'Intermediate vision'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about the intermediate and near vision in patiënts who underwent cataract surgery with a specific technique, called "bag in the lens".\n\nThe main question it aims to answer is whether patiens who underwent this type of cataract surgery have better intermediate vision without spectacle correction than patients who underwent the classic lens in the bag cataract surgery.\n\nParticipants will:\n\n* Have to read with and without spectacle correction at different distances (4 meters, 66 centimeters, 40 centimeters)\n* Have to fill in 2 questionnaires about visual functioning and spectacle independance\n\nResearchers will compare these values to the same values from the standard population who underwent the classic lens in the bag cataract surgery with a monofocal intraocular lens .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent bilateral bag in the lens cataract surgery in the University Hospital Brussels at least 3 months before inclusion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of at least 18 years old\n* Must have underwent bilateral bag in the lens cataract surgery in the University hospital Brussels at least 3 months before inclusion\n* Must not meet any exclusion criteria\n\nExclusion Criteria:\n\n* Prior refractive surgery (other than bag in the lens)\n* Glaucoma\n* Corneal opacities\n* Moderate non proliferative diabetic retinopathy or worse\n* Optic neuropathy\n* History of uveitis\n* Amblyopia\n* Residual post-operative astigmatism higher than 1.5 Diopters (D)\n* Best corrected visual acuity \\< 1.0\n* Patients unable to cooperate or sign the informed consent'}, 'identificationModule': {'nctId': 'NCT06364761', 'briefTitle': 'Assesment of Intermediate Vision After BIL Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Assesment of Intermediate and Near Vision After Bag in the Lens Cataract Surgery', 'orgStudyIdInfo': {'id': '24103_BIL_EDOF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bag in the lens', 'description': 'Patients who underwent bag in the lens cataract surgery at least 3 months before inclusion in the University Hospital Brussels, Belgium.', 'interventionNames': ['Procedure: Bag in the lens cataract surgery']}], 'interventions': [{'name': 'Bag in the lens cataract surgery', 'type': 'PROCEDURE', 'description': 'Cataract surgery using the Morcher 89A intraocular lens', 'armGroupLabels': ['Bag in the lens']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jorgos Koulalis, M.D.', 'role': 'CONTACT', 'email': 'jorkoul@hotmail.com', 'phone': '+32474045858'}], 'overallOfficials': [{'name': 'Jorgos Koulalis, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}