Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-10 @ 8:35 AM
Study NCT ID:
NCT01906151
Status:
WITHDRAWN
Last Update Posted:
2014-05-13
First Post:
2013-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2013-07-19', 'studyFirstSubmitQcDate': '2013-07-19', 'lastUpdatePostDateStruct': {'date': '2014-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the differences between the nycthemeral intraocular pressure patterns recorded with Triggerfish during two 24-hour periods, in patients with Primary angle closure and Primary angle closure glaucoma, before and after laser peripheral iridotomy', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'To assess the nycthemeral intraocular pressure patterns specific to primary angle closure and primary angle closure glaucoma', 'timeFrame': '24 hours'}, {'measure': 'To assess the effect of laser peripheral iridotomy on diurnal and nocturnal intraocular pressure pattern in primary angle closure and primary angle closure glaucoma', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the relationship of the intraocular pressure patterns recorded during 2 sessions using Triggerfish, before and after elective laser peripheral iridotomy in angle closure glaucoma patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Primary Angle Closure (PAC) or Primary Angle Closure Glaucoma (PACG) with indication for Laser Peripheral Iridotomy (LPI). PAC is defined by the presence of a partial or complete iridotrabecular contact(ITC) in more than 2 quadrants with either raised intraocular pressure (IOP) (ie. more than 21 mmHg) and/or PAS; however, with normal optic disc and visual field. PACG is defined by the presence of ITC with either raised IOP and/or PAS, and evidence of glaucomatous optic disc and visual field\n* No IOP-lowering drug treatment or a 4-week wash-out period prior to Study Day 0\n* Aged ≥18 years, of either sex\n* Not more than 6 diopters spherical equivalent on the study eye\n* Have given written informed consent, prior to any investigational procedures\n\nExclusion Criteria:\n\n* History of acute angle closure glaucoma on the study eye\n* Secondary angle closure glaucoma on the study eye\n* History of ocular surgery within the last 3 months on the study eye\n* History of ocular laser treatment, including previous LPI on the study eye\n* Corneal or conjunctival abnormality precluding contact lens adaptation on the study eye\n* Severe dry eye syndrome on the study eye\n* Patients with allergy to corneal anesthetic\n* Patients with contraindications for silicone contact lens wear\n* Patients not able to understand the character and individual consequences of the investigation'}, 'identificationModule': {'nctId': 'NCT01906151', 'briefTitle': 'IOP Pattern in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After LPI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sensimed AG'}, 'officialTitle': 'A Prospective, Open Label Study Assessing the 24-hour Intraocular Pressure Pattern Monitored by SENSIMED Triggerfish® in Primary Angle Closure and Primary Angle Closure Glaucoma Patients, Before and After Laser Peripheral Iridotomy', 'orgStudyIdInfo': {'id': 'TF-1306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SENSIMED Triggerfish®', 'description': 'SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization', 'interventionNames': ['Device: SENSIMED Triggerfish®']}], 'interventions': [{'name': 'SENSIMED Triggerfish®', 'type': 'DEVICE', 'description': 'SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization', 'armGroupLabels': ['SENSIMED Triggerfish®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75571', 'city': 'Paris', 'country': 'France', 'facility': 'CHNO des Quinze-Vingts, 28 rue Charenton', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Christophe Baudouin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHNO des Quinze-Vingts, 28 rue Charenton, 75571 Paris Cedex 12, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sensimed AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}