Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-03-25 @ 12:48 AM
Study NCT ID:
NCT02209961
Status:
UNKNOWN
Last Update Posted:
2014-08-06
First Post:
2014-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-05', 'studyFirstSubmitDate': '2014-03-19', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure change in Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .', 'timeFrame': 'within one to two years post surgery', 'description': 'to check the change in intraocular pressure after EX-PRESS shunt implantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glaucoma and Ocular Hypertension']}, 'descriptionModule': {'briefSummary': 'A prospective study reporting on Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery.', 'detailedDescription': 'The occurrence of both glaucoma and clinically relevant cataract in the same individual is a frequent condition, especially in the elderly population. Besides age, this might be related to the possible role of antiglaucoma medications in the progression of lens opacity.When both procedures are required, these can be performed separately or in combination.\n\nGlaucoma filtering surgery is indicated when glaucomatous damage progresses despite the lower level of intraocular pressure (IOP) obtained with pharmacological and/or laser treatment.\n\nThe Ex-PRESS is a miniature stainless steel glaucoma device, developed as an alternative to trabeculectomy and to the other types of glaucoma filtering surgery for patients with POAG. This procedure would be theoretically more reproducible and simple to perform as well as less traumatic to the ocular tissue than traditional filtering surgery. The implant is inserted at the limbus under a conjunctival flap and diverts the aqueous humour from the anterior chamber to the subconjunctival space, obtaining the formation of a conjunctival filtration bleb, in a similar way to trabeculectomy. This procedure can be performed on its own or in combination with phacoemulsification.\n\nThis study is aimed to test the efficacy and saftey of Ex-PRESS shunt implantation alone or combined cataract and glaucoma surgery in patients with medically uncontrolled glaucoma and cataract .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with uncontrolled glaucoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- age above 18\n\nExclusion Criteria:\n\n\\- congenital glaucoma'}, 'identificationModule': {'nctId': 'NCT02209961', 'briefTitle': 'Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'To Check the Efficacy and Saftey of Combined Ex-PRESS Implantation Alone or With Phacoemulsification for Glaucoma Associated With Cataract', 'orgStudyIdInfo': {'id': '0054-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'glaucoma and ocular hypertension', 'description': 'glaucoma and ocular hypertension'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rana N Hanna, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}