Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT05500469
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-08-11', 'studyFirstSubmitQcDate': '2022-08-11', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', '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': 'ECD', 'timeFrame': 'Baseline, 6, 12 and 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 and 24 months', 'description': 'Intraocular pressure'}, {'measure': 'Position of the tube', 'timeFrame': 'Baseline, 6, 12 and 24 months', 'description': 'Position of the tube on anterior segment OCT'}, {'measure': 'Adverse events', 'timeFrame': 'Time of surgery, 1, 3, 6, 12, 24 months', 'description': 'Complications at the time of surgery, postoperative adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Rationale: Glaucoma is a group of diseases characterized by progressive neuropathy of the optic nerve associated with visual field loss. Current glaucoma management aims to preserve visual function throughout life by reducing the intraocular pressure. This can be achieved by medical therapy or by surgical procedures such as implantation of a glaucoma drainage device (GDD). Conventionally, the tube of such a device is positioned in the anterior chamber (AC). Unfortunately, the presence of the tube in the AC may have a significant negative impact on the number of endothelial cells of the cornea and may even lead to corneal decompensation. Alternatively, the tube can be positioned in the posterior chamber (i.e. behind the iris). In this study, both procedures will be compared.\n\nObjective: Primary: to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris. Secondary: to compare efficacy and safety of both procedures.\n\nStudy design: Prospective, randomised, treatment controlled clinical trial. Study population: Pseudophakic patients with glaucoma who need a GDD. Intervention: Implantation of a Paul GDD with its tube anterior/posterior of the iris. Main study parameters/endpoints: Endothelial cell loss of the cornea.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: At present potential benefits and drawbacks of positioning the Paul tube behind the iris are insufficiently known, successful positioning of the tube may require slightly more surgery time and the risk of hyphaema may be higher. It is expected, that in the long run damage to the corneal endothelium is less. Risks of study-related assessments are negligible, burden is low, extra time is about 35+15+35+35 minutes (total 2h).'}, '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* Pseudophakic\n* Open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or angle closure glaucoma with sufficiently deep anterior chamber\n* Endothelial image at baseline of fair or good quality\n\nExclusion Criteria:\n\n* Iridocorneal endothelial syndrome or posterior polymorphous dystrophy\n* Eyes with a history of penetrating trauma\n* Eyes with a history of (intra)ocular surgery other than uncomplicated cataract surgery\n* Eyes with corneal disease\n* Synechiae posterior\n* Pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT05500469', 'briefTitle': 'Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Oogziekenhuis Rotterdam'}, 'officialTitle': 'Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OZR-2022-03'}, 'secondaryIdInfos': [{'id': 'NL81305.078.22', 'type': 'OTHER', 'domain': 'CCMO'}, {'id': 'MEC-2022-0364', 'type': 'OTHER', 'domain': 'MEC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GDD-tube in anterior chamber', 'description': 'The Paul 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 or nasal quadrant of the eye. The tube is positioned in the anterior chamber.', 'interventionNames': ['Device: Paul glaucoma drainage device (GDD)']}, {'type': 'EXPERIMENTAL', 'label': 'GDD-tube in posterior chamber', 'description': 'The Paul 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 or nasal quadrant of the eye. The tube is positioned in the posterior chamber.', 'interventionNames': ['Device: Paul glaucoma drainage device (GDD)']}], 'interventions': [{'name': 'Paul glaucoma drainage device (GDD)', 'type': 'DEVICE', 'description': 'Implantation of the GDD', 'armGroupLabels': ['GDD-tube in anterior chamber', 'GDD-tube in posterior chamber']}]}, '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': 'Peter de Waard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oogziekenhuis Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Rene 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'}}}}