Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT05344651
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of endothelial cell density (ECD).', 'timeFrame': 'Baseline and 2 years', 'description': 'ECD will be assessed at the center of the cornea and close to the tube.'}], 'secondaryOutcomes': [{'measure': 'Endothelial cell density (ECD).', 'timeFrame': 'Baseline, 3, 6, 12, 24 months.', 'description': 'ECD will be assessed at the center of the cornea and close to the tube.'}, {'measure': 'Intraocular pressure.', 'timeFrame': 'Baseline, 1, 3, 6, 12, 24 months.', 'description': 'Intraocular pressure.'}, {'measure': 'Orthoptic assessment.', 'timeFrame': 'Baseline, 3, 6, 12, 24 months.', 'description': 'Prism cover test: total deviation at 30 cm; Goldmann: monocular ductions in 8 directions starting from primary position, binocular field of single vision.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage.\n\nObjective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.\n\nStudy design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years.\n* Informed consent.\n* Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents.\n* Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.\n\nExclusion Criteria:\n\n* History of intraocular surgery (e.g. vitrectomy, cataract surgery, cyclodestructive procedures etc).\n* History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).\n* Pseudophakia.\n* Functionally monocular patients.\n* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery.\n* Narrow anterior chamber angle.\n* Best corrected visual acuity less than 0.1.\n* Severe blepharitis.'}, 'identificationModule': {'nctId': 'NCT05344651', 'briefTitle': 'Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium', 'organization': {'class': 'OTHER', 'fullName': 'Oogziekenhuis Rotterdam'}, 'officialTitle': 'Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium', 'orgStudyIdInfo': {'id': 'OZR-2020-30'}, 'secondaryIdInfos': [{'id': 'NL80518.078.22', 'type': 'OTHER', 'domain': 'Centrale Commissie Mensgebonden Onderzoek'}, {'id': 'MEC-2022-0069', 'type': 'OTHER', 'domain': 'Medical Ethical Committe of the Erasmus Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Baerveldt glaucoma drainage device', 'interventionNames': ['Device: Surgery/implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Paul glaucoma drainage device', 'interventionNames': ['Device: Surgery/implantation']}], 'interventions': [{'name': 'Surgery/implantation', 'type': 'DEVICE', 'description': 'The glaucoma drainage device consists of a plate and a tube. During surgery the plate is positioned underneath the conjunctiva and two extraocular muscles in the upper temporal quadrant of the eye. The tube is positioned in the anterior chamber.', 'armGroupLabels': ['Baerveldt glaucoma drainage device', 'Paul glaucoma drainage device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3011BH', 'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Rene J Wubbels, PhD', 'role': 'CONTACT', 'email': 'r.wubbels@oogziekenhuis.nl', 'phone': '+31104023430'}, {'name': 'Ionela Popescu-Giovanitsas, MD', 'role': 'CONTACT', 'email': 'I.Popescu@oogziekenhuis.nl', 'phone': '+31104023447'}, {'name': 'Jan Geert Bollemeijer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oogziekenhuis Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Rene J Wubbels', 'role': 'CONTACT', 'email': 'r.wubbels@oogziekenhuis.nl', 'phone': '+31104023430'}, {'name': 'Susan Marinissen', 'role': 'CONTACT', 'email': 'S.Marinissen@oogziekenhuis.nl', 'phone': '+31104023449'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oogziekenhuis Rotterdam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}