Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 5:21 AM
Study NCT ID:
NCT01798966
Status:
COMPLETED
Last Update Posted:
2016-03-11
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anjalism@gmail.com', 'phone': '+1858 822-1553', 'title': 'Anjali Parekh', 'organization': 'Hamilton Glaucoma center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From inform consent signature to 30 days after last exposure to device', 'eventGroups': [{'id': 'EG000', 'title': 'SENSIMED Triggerfish', 'description': 'All patients included in the device group', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild hyperemia and palpebral conjunctiva', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 10}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Punctate keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in IOP Before and After Orbital Decompression Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SENSIMED Triggerfish', 'description': 'SENSIMED Triggerfish worn for 24h'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'spread': '43.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 hours', 'description': 'To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression', 'unitOfMeasure': 'mVEq (Sensismed Triggerfish output unit)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'IOP Patterns', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SENSIMED Triggerfish', 'description': 'All patients included in the device group'}], 'classes': [{'categories': [{'measurements': [{'value': '102.2', 'spread': '52.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients', 'unitOfMeasure': 'mvEq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Adverse Events and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SENSIMED Triggerfish', 'description': 'SENSIMED Triggerfish worn for 24h'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 days', 'description': 'Safety will be evaluated throughout the duration of the study by collecting all adverse events', 'unitOfMeasure': 'Number of AE', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SENSIMED Triggerfish', 'description': 'All patients included in the device group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SENSIMED Triggerfish', 'description': 'All patients included in the device group'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '21.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tolerability of CLS', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Subjective comfort level using a number between 0-10 with values ranging from 0 (no discomfort) to 10 (very severe discomfort)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-15', 'studyFirstSubmitDate': '2013-02-21', 'resultsFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2013-02-22', 'lastUpdatePostDateStruct': {'date': '2016-03-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-20', 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse Events and Serious Adverse Events', 'timeFrame': '4 days', 'description': 'Safety will be evaluated throughout the duration of the study by collecting all adverse events'}], 'primaryOutcomes': [{'measure': 'Change in IOP Before and After Orbital Decompression Surgery', 'timeFrame': '24 hours', 'description': 'To investigate the difference in SENSIMED Triggerfish output during transition from wake to sleep states before and after orbital decompression'}], 'secondaryOutcomes': [{'measure': 'IOP Patterns', 'timeFrame': '24 hours', 'description': 'The pattern of IOP in patients with TED will be compared with the pattern of IOP readings in normal subjects as well as glaucomatous patients'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Thyroid Eye Disease']}, 'descriptionModule': {'briefSummary': 'Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher orbital fat contents due to their disease process. The confined space of the orbit cannot hold the enlarged orbital contents creating a forward displacement and/or compression of the globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical decompression, a procedure that fractures orbital bones, in order to allow more space for the enlarged orbital contents to occupy. To date, there is no data that shows intraocular patterns over a 24-hour period in patients with mechanical compression on the globe as in TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns, glaucomatous patterns, or perhaps completely different then either. The goal of this project is to investigate patterns of IOP in patients requiring orbital decompression because of orbital congestion. Changes in IOP during a 24-hour period will be studied with a contact-lens embedded sensor that provides continuous data. This device has previously been investigated and shown to be safe and well-tolerated. Monitoring the pattern in these patients will allow us to compare Thyroid TED patterns of IOP with those of normal and glaucomatous patients. Also, testing these patients before and after orbital decompression surgery will allow characterization of how intraocular pressure changes once the mechanical compression on the globe is relieved.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able to comply with the study procedures\n* 18-80 years old\n* Subjects diagnosed with Thyroid Eye Disease based on both endocrinology studies showing autoimmune dysfunction consistent with Graves' Disease as well as orbital imaging studies manifesting characteristics consistent with Thyroid Eye Disease.\n* Ability to understand the character and individual consequences of the study\n* Subject has consented to be in the trial\n\nExclusion Criteria:\n\n* Subjects with contraindications for wearing contact lenses\n* Severe ocular surface disease\n* Keratoconus or other corneal abnormality\n* Severe ocular inflammation\n* Full frame metal glasses during SENSIMED Triggerfish® monitoring\n* Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)\n* Simultaneous participation in other clinical studies\n* Diagnosis of glaucoma"}, 'identificationModule': {'nctId': 'NCT01798966', 'briefTitle': 'Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sensimed AG'}, 'officialTitle': 'The Effects of Orbital Decompression Surgery on Intraocular Pressure Patterns in Patient With Thyroid Eye Disease Undergoing 24 Hour Continuous IOP Monitoring With the SENSIMED Triggerfish®', 'orgStudyIdInfo': {'id': 'TF-1111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SENSIMED Triggerfish', 'description': 'Sensimed Triggerfish device will be worn by each subject for 24h', 'interventionNames': ['Device: SENSIMED Triggerfish']}], 'interventions': [{'name': 'SENSIMED Triggerfish', 'type': 'DEVICE', 'otherNames': ['Contact lens sensor intented to continuously record IOP pattern for up to 24 hours'], 'armGroupLabels': ['SENSIMED Triggerfish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0496', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Shiley Eye Center, University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Donald O Kikkawa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Diego'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sensimed AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of California, San Diego', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}