Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-27 @ 3:51 PM
Study NCT ID:
NCT04397068
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-07-26', 'releaseDate': '2022-08-30'}], 'estimatedResultsFirstSubmitDate': '2022-08-30'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-16', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2020-05-16', 'lastUpdatePostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare if ELP is different or the same at phaco or phaco-vitrectomy', 'timeFrame': '6 - 8 weeks', 'description': 'Anterior chamber depth measured using IOL master.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Pucker']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to gain more insight into the potential impact of a vitrectomy (removal of the vitreous) on postoperative effective position of the intraocular lens (IOL). Moreover, this study can provide very useful information for the optimal lens calculation in patients undergoing lens extraction with IOL implantation (whether or not combined with a vitrectomy) should undergo.', 'detailedDescription': '* Comparison ELP post phaco VTX (pucker / floaters) versus post phaco and use this information to develop a customized IOL calculation for eyes undergoing phacoVTX.\n* Evidence for recording lens thickness (LT) parameter in the IOL strength calculation in KWS (in the calculation of the ELP in the light of the Olsen formula, using the C-constant) in order to be able to make an even more accurate prediction of the post-operative diopter target of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 50 yrs\n* macular pucker wherefore vitrectomy is necessary\n\nExclusion Criteria:\n\n* macular pathology other than macular pucker\n* Corneal pathology\n* Other ocular pathology that could affect the biometrics or ELP\n* Previous vitrectomy in one of the eyes'}, 'identificationModule': {'nctId': 'NCT04397068', 'acronym': 'ELP', 'briefTitle': 'Compare ELP in Patients With Elective Phaco-VTX Surgery in One Eye and a Single Lens Phaco Surgery on the Other Eye', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Vergelijking Van de Postoperatieve Effectieve Lenspositie (ELP) Bij patiënten Gepland Voor Een Electieve Phacovitrectomie-ingreep (Phaco-VTX) Aan één Oog en Enkel Een Lensingreep Phaco Aan Het Andere Oog', 'orgStudyIdInfo': {'id': 'S58904'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'macular pucker wherefore vitrectomy', 'description': 'one eye phaco-vitrectomy and other eye only phaco. No other involvement of drug or device. Standard of care procedure', 'interventionNames': ['Procedure: phaco-vitrectomy']}], 'interventions': [{'name': 'phaco-vitrectomy', 'type': 'PROCEDURE', 'description': 'phaco-vitrectomy. No other involvement drug or device. Standard of care procedure', 'armGroupLabels': ['macular pucker wherefore vitrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitaire Ziekenhuizen Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Peter Stalmans', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd, MD', 'investigatorFullName': 'Prof. Dr. Peter Stalmans', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-08-30', 'type': 'RELEASE'}, {'date': '2023-07-26', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Prof. Dr. Peter Stalmans, Phd, MD, Universitaire Ziekenhuizen KU Leuven'}}}}