Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-28 @ 10:33 PM
Study NCT ID:
NCT03613233
Status:
UNKNOWN
Last Update Posted:
2018-08-03
First Post:
2018-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QoL Assessment in Traditional Glaucoma Surgery and MIGS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-29', 'studyFirstSubmitDate': '2018-06-29', 'studyFirstSubmitQcDate': '2018-07-29', 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NEI VFQ 25 quality of life score change', 'timeFrame': 'baseline (0-30 days; pre-operative) and three months after surgery', 'description': 'NEI VFQ 25 baseline and 3 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MIGS', 'canaloplasty', 'glaucoma', 'glaucoma surgery', 'glaucoma implant', 'deep sclerectomy', 'iridencleisis', 'QoL', 'quality of life', 'NEI VFQ 25'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).', 'detailedDescription': 'Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:\n\n* all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression\n* patients not tolerating antiglaucoma medications,\n* patients with poor compliance\n* progression in visual field\n\nExclusion Criteria:\n\n* active inflammatory disease\n* pregnancy\n* mental disease or emotional instability\n* general steroid therapy\n* inability to fill in the questionnaire'}, 'identificationModule': {'nctId': 'NCT03613233', 'briefTitle': 'QoL Assessment in Traditional Glaucoma Surgery and MIGS.', 'organization': {'class': 'OTHER', 'fullName': 'Military Institute od Medicine National Research Institute'}, 'officialTitle': 'Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.', 'orgStudyIdInfo': {'id': '0000000417'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'traditional glaucoma surgery', 'description': 'glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy', 'interventionNames': ['Procedure: Glaucoma surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'microinvasive glaucoma surgery (MIGS)', 'description': 'glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device', 'interventionNames': ['Procedure: Glaucoma surgery']}], 'interventions': [{'name': 'Glaucoma surgery', 'type': 'PROCEDURE', 'otherNames': ['cataract surgery when required'], 'description': 'phacoemulsification', 'armGroupLabels': ['microinvasive glaucoma surgery (MIGS)', 'traditional glaucoma surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04-141', 'city': 'Warsaw', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Anna Byszewska, MD,PhD', 'role': 'CONTACT', 'email': 'ania.byszewska@gmail.com', 'phone': '500285890', 'phoneExt': '48'}], 'facility': 'Military Institute of Medicine', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Anna Byszewska, MD, PhD', 'role': 'CONTACT', 'email': 'ania.byszewska@gmail.com', 'phone': '500285890', 'phoneExt': '48'}, {'name': 'Marek Rękas, prof.; MD; PhD', 'role': 'CONTACT', 'email': 'mrekas@wim.mil.pl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Military Institute od Medicine National Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'płk prof. Marek RĘKAS, MD, PhD', 'investigatorFullName': 'Marek Rekas', 'investigatorAffiliation': 'Military Institute od Medicine National Research Institute'}}}}