Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-03 @ 11:19 PM
Study NCT ID:
NCT02336334
Status:
COMPLETED
Last Update Posted:
2016-07-19
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Posturing-Adherence in Patients After Intraocular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2015-01-12', 'lastUpdatePostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effective time of ideal posturing with different sensors-systems', 'timeFrame': 'up to 12 month', 'description': 'Time (measured in minutes and in percent of 24h) with correct posturing in relation to the used sensor-type (with and without feedback)'}], 'secondaryOutcomes': [{'measure': 'Time analysis with optimal posturing after detailed explanation of posturing positions', 'timeFrame': 'up to 12 month', 'description': 'Time (measured in minutes and in percent of 24h) with correct posturing in patients which received an detailed posturing explanation (with graphics)'}, {'measure': 'Analysis of time with optimal posturing for both Sensor-Feedback-Systems', 'timeFrame': 'up to 12 month', 'description': 'Time (measured in minutes and in percent of 24h) with correct posturing depending on the used sensor-type (noise vs. vibration)'}, {'measure': 'Closure rate of macular holes after 3 month as measured by optical coherence tomography (hole closed: yes or no)', 'timeFrame': 'up to 12 month', 'description': 'Status of macular holes after 3 month in macular hole group measured by optical coherence tomography (hole closed: yes or no) and in relation to time with optimal posturing'}, {'measure': 'Tolerability of sensor-systems for patients as measured by questionnaire', 'timeFrame': 'up to 12 month', 'description': 'Using a questionnaire patients are asked to give their view on the tolerability of the used system.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Retina; Lesion', 'Adherence']}, 'descriptionModule': {'briefSummary': 'Measuring and logging head positions of patients which underwent surgery with gasendotamponades.', 'detailedDescription': 'After surgery with gasendotamponades various positions are recommended to support the success of surgery. In patients with macular holes face-down-position is recommended. In patients with retinal detachment the recommended position depends on the region of the detachment.\n\nThe adherence of patients to follow this posturing instructions is very inhomogenous. Therefore the investigators want to measure the posturing by the use of a position-sensor. In some study arms the patients also receive a feedback from the sensor (tone, vibration) to correct the position.\n\nThe sensor-device was developed by the study-staff and is not commercial available. In addition there is no trade name. The patients safety of the used device was approved by the in house technical department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* full thickness macular hole or retinal detachment\n* informed consent\n\nExclusion Criteria:\n\n* intraoperative complications with the need of other endotamponades\n* combined treatment'}, 'identificationModule': {'nctId': 'NCT02336334', 'briefTitle': 'Evaluation of Posturing-Adherence in Patients After Intraocular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Measurement and Logging of Posturing Adherence of Patients After Intraocular Surgery With Gasendotamponades Using a Sensorsystem With Different Feedback-Methods', 'orgStudyIdInfo': {'id': 'PosturingSensor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With macular hole', 'description': 'Inclusion of patients with macular holes and randomized allocation to sensor-types and information-types\n\nInterventions:\n\nPositioning measurement Patient feedback Usefulness of a sketch Closure rate of macular holes', 'interventionNames': ['Device: Positioning measurement', 'Device: Patient feedback', 'Procedure: Usefulness of a sketch', 'Device: Closure rate of macular holes']}, {'type': 'EXPERIMENTAL', 'label': 'Without macular hole', 'description': 'Inclusion of patients without macular holes and randomized allocation to sensor-types and information-types\n\nInterventions:\n\nPositioning measurement Patient feedback Usefulness of a sketch', 'interventionNames': ['Device: Positioning measurement', 'Device: Patient feedback', 'Procedure: Usefulness of a sketch']}], 'interventions': [{'name': 'Positioning measurement', 'type': 'DEVICE', 'description': 'Logging of posturing informations', 'armGroupLabels': ['With macular hole', 'Without macular hole']}, {'name': 'Patient feedback', 'type': 'DEVICE', 'description': 'Evaluation of patients questionary', 'armGroupLabels': ['With macular hole', 'Without macular hole']}, {'name': 'Usefulness of a sketch', 'type': 'PROCEDURE', 'description': 'Helping the patients to understand posturing positions by randomized allocation of sketches', 'armGroupLabels': ['With macular hole', 'Without macular hole']}, {'name': 'Closure rate of macular holes', 'type': 'DEVICE', 'description': 'closure rates of macular holes in the group with macular holes. Measurement using SD-OCT (spectral domain optical coherence tomography=', 'armGroupLabels': ['With macular hole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University Eye Hospital', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}