Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-24 @ 12:26 AM
Study NCT ID:
NCT03114059
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2017-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
5 Years Long Term Results After Standalone CyPass-Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'a.medra@live.com', 'phone': '+49 395 775 13483', 'title': 'Ahmed Medra', 'organization': 'Dietrich-Bonhoeffer-Klinikum'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago\n\nGlaucoma diagnostics: Heidelberg, Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological determination', 'otherNumAtRisk': 75, 'deathsNumAtRisk': 75, 'otherNumAffected': 1, 'seriousNumAtRisk': 75, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Allergic reaction', 'notes': 'itching, watery secretion, redning of the lids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 75, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'title': 'Target pressure achieved - without medication', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Target pressure achieved - with medication', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Target pressure not achieved', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'only 75 study patients were able to visit the clinic and to undergone the 5 year examination, therefore we only could analyse the data of theses75 patients. The number of 230 Patients discribes all patients that fullfil the inclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'title': 'preoperative', 'categories': [{'measurements': [{'value': '21.127', 'spread': '7.831', 'groupId': 'OG000'}]}]}, {'title': 'postoperative', 'categories': [{'measurements': [{'value': '16.553', 'spread': '6.633', 'groupId': 'OG000'}]}]}, {'title': 'change', 'categories': [{'measurements': [{'value': '-4.697', 'spread': '8.212', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 7 years', 'description': 'The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg)\n\nThe change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Additional Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'title': 'preoperative', 'categories': [{'measurements': [{'value': '1.813', 'spread': '1.182', 'groupId': 'OG000'}]}]}, {'title': 'postoperative', 'categories': [{'measurements': [{'value': '2.014', 'spread': '1.053', 'groupId': 'OG000'}]}]}, {'title': 'change', 'categories': [{'measurements': [{'value': '0.173', 'spread': '1.201', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 7 years', 'description': 'The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent.\n\nThe postoperative number of medications after 5 years has to be compared with the preoperative number', 'unitOfMeasure': 'numbers of active substances', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Secondary Glaucoma Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stability of Optic Nerve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'title': 'stable', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}, {'title': 'not stable', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure.\n\nWith papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'for 7 eyes this examination was not done due to low compliance'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'title': 'stable', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'worsening', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stability of Visual Field', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'title': 'improvement', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'stable', 'measurements': [{'value': '49', 'groupId': 'OG000'}]}, {'title': 'progression', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure. The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stability of Stent Position', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'title': 'Stent is stable', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Stent moves deeper', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Stent emerges', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': "Determination of Stent Position in the angle will be performed to exclude moving of the Stent. The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Stability of Stent Tissue Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'title': 'stable', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'slight adhesions', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'severe adhesions', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'Determination of iris tissue reaction to the stent will be performed. We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue. The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed is not consistent with numbers provided in any of the rows in the Participant Flow module. The discrepancy is caused by insufficient cooperation (due to old age or poor general condition) of individual participants to carry out this examination to the end'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Intra-and Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'title': 'resistance during implantation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'heavy bleeding (intraoperative)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'bad stent positioning', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'increase in pressure: early postoperative', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'increase in pressure', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'increase in pressure: glaucomatous attack', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'hyphema', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'hypotonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'early contact to the endothelium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'age-related macula degeneration', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'gliosis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'macula edema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'keratitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'dry eyes symptoms', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'fibrin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'stroke', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'uveitis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'cataract progression', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'secondary cataract', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'lid tumor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'pain during operation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'recurrent neuritis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'retroiridal cyst', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'total number of complications', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}, {'title': 'total number of affected eyes', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Suprachoroidal Bleb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'classes': [{'categories': [{'title': 'none', 'measurements': [{'value': '44', 'groupId': 'OG000'}]}, {'title': 'small', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'big', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 7 years', 'description': 'The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure. The bigger the bleb, the lower the pressure and the better the efficacy of the stent', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'for 12 eyes this examination was not done due to low compliance'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Standalone CyPass Implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '165', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69', 'spread': '12.095', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'all patients that undergone a standalone Cypass-implantation'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-07', 'size': 508972, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-03-12T05:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-17', 'studyFirstSubmitDate': '2017-04-04', 'resultsFirstSubmitDate': '2021-08-17', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-17', 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg', 'timeFrame': 'up to 7 years', 'description': 'The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.'}, {'measure': 'Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)', 'timeFrame': 'up to 7 years', 'description': 'The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg)\n\nThe change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point'}, {'measure': 'Number of Additional Medication', 'timeFrame': 'up to 7 years', 'description': 'The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent.\n\nThe postoperative number of medications after 5 years has to be compared with the preoperative number'}, {'measure': 'Number of Participants With Secondary Glaucoma Procedures', 'timeFrame': 'up to 7 years', 'description': 'To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Stability of Optic Nerve', 'timeFrame': 'up to 7 years', 'description': 'The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure.\n\nWith papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings.'}, {'measure': 'Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness', 'timeFrame': 'up to 7 years', 'description': 'The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success.'}, {'measure': 'Number of Participants With Stability of Visual Field', 'timeFrame': 'up to 7 years', 'description': 'The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure. The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field.'}, {'measure': 'Number of Participants With Stability of Stent Position', 'timeFrame': 'up to 7 years', 'description': "Determination of Stent Position in the angle will be performed to exclude moving of the Stent. The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space"}, {'measure': 'Number of Participants With Stability of Stent Tissue Interaction', 'timeFrame': 'up to 7 years', 'description': 'Determination of iris tissue reaction to the stent will be performed. We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue. The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed.'}, {'measure': 'Number of Participants With Intra-and Postoperative Complications', 'timeFrame': 'up to 7 years', 'description': 'The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure'}, {'measure': 'Number of Participants With Suprachoroidal Bleb', 'timeFrame': 'up to 7 years', 'description': 'The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure. The bigger the bleb, the lower the pressure and the better the efficacy of the stent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Late Effects of Surgery'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '25304276', 'type': 'BACKGROUND', 'citation': 'Hoeh H, Vold SD, Ahmed IK, Anton A, Rau M, Singh K, Chang DF, Shingleton BJ, Ianchulev T. Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent. J Glaucoma. 2016 Jan;25(1):106-12. doi: 10.1097/IJG.0000000000000134.'}, {'pmid': '25747677', 'type': 'BACKGROUND', 'citation': 'Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.'}, {'pmid': '23958836', 'type': 'BACKGROUND', 'citation': 'Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick HB, Grisanti S. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6. German.'}, {'pmid': '24771171', 'type': 'BACKGROUND', 'citation': 'Hoh H, Grisanti S, Grisanti S, Rau M, Ianchulev S. Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent. Klin Monbl Augenheilkd. 2014 Apr;231(4):377-81. doi: 10.1055/s-0034-1368214. Epub 2014 Apr 25.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure. The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery', 'detailedDescription': 'This is a post market study without interventions.The participants have been treated with CyPass-Stent implantation between 3 and 7 years ago to control the intraocular pressure . They will be invited for only one follow up visit to determine the present glaucoma status again, to determine the long term safety and effectiveness of the cypass stent procedure and to see whether addition therapy or surgical intervention is necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '130 Patient with at least one treated eye', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who have undergone a standalone cypass implantation at least 3 years ago\n* signed inform consent\n\nExclusion Criteria:\n\n* Patients with too much travel distance between study center and home\n* Patients who cannot visit the studycenter due to health problems'}, 'identificationModule': {'nctId': 'NCT03114059', 'briefTitle': '5 Years Long Term Results After Standalone CyPass-Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dietrich-Bonhoeffer-Klinikum'}, 'officialTitle': 'Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation', 'orgStudyIdInfo': {'id': 'STI 06/16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'standalone CyPass implantation', 'description': 'patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago', 'interventionNames': ['Diagnostic Test: Glaucoma diagnostics']}], 'interventions': [{'name': 'Glaucoma diagnostics', 'type': 'DIAGNOSTIC_TEST', 'description': 'Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination', 'armGroupLabels': ['standalone CyPass implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17036', 'city': 'Neubrandenburg', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Dietrich-Bonhoeffer-Klinikum', 'geoPoint': {'lat': 53.55735, 'lon': 13.26105}}], 'overallOfficials': [{'name': 'Helmut Hoeh, MD,FEBO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, Neubrandenburg, Germany'}]}, 'ipdSharingStatementModule': {'timeFrame': 'results are planned to published in December 2020', 'ipdSharing': 'YES', 'description': 'results will be published in ophthalmological journals', 'accessCriteria': 'Publication in ophthalmological journals provided and checked by Ahmed Medra'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dietrich-Bonhoeffer-Klinikum', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}