Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT05548959
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2022-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outflow Facility AIT vs Microshunt
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure variation', 'timeFrame': 'Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).', 'description': '24-hour variation in intraocular pressure obtained by the use of a pneumatonometer.'}], 'secondaryOutcomes': [{'measure': 'Outflow facility', 'timeFrame': 'Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).', 'description': 'Outflow facility of the aqueous humor from the eye obtained by pneumatonography.'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).', 'description': 'Intraocular pressure obtained by the use of a Pneumatonometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['outflow facility', 'microshunt', 'ab interno trabeculectomy', 'pneumatonometer', 'intraocular pressure'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.', 'detailedDescription': 'Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.\n\nNo study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).\n\nIn this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago\n* patients suffering from open-angle glaucoma\n\nExclusion Criteria:\n\n* Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago\n* patients suffering from angle-closure glaucoma'}, 'identificationModule': {'nctId': 'NCT05548959', 'briefTitle': 'Outflow Facility AIT vs Microshunt', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery', 'orgStudyIdInfo': {'id': '114/21me'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microshunt patients', 'description': 'Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous microshunt implantation.', 'interventionNames': ['Diagnostic Test: Pneumatonometry after microshunt implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Ab interno trabeculectomy patientes', 'description': 'Pneumatonometry of the intraocular pressure was performed on patients who have undergone previous ab interno trabeculectomy.', 'interventionNames': ['Diagnostic Test: Pneumatonometry after ab interno trabeculectomy']}], 'interventions': [{'name': 'Pneumatonometry after microshunt implantation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position.', 'armGroupLabels': ['Microshunt patients']}, {'name': 'Pneumatonometry after ab interno trabeculectomy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pneumatonometry was perfomed over 24 hours at 5 point in time (5 AM, 11 AM, 4 PM, 8 PM, and midnight) using a Pneumatonometer. The measurement was conducted in the habitual position.', 'armGroupLabels': ['Ab interno trabeculectomy patientes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97070', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Ophthalmology University Hospital Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}