Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2026-01-13 @ 3:23 AM
Study NCT ID:
NCT02807935
Status:
UNKNOWN
Last Update Posted:
2016-06-23
First Post:
2016-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-22', 'studyFirstSubmitDate': '2016-06-17', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Mean SC (schlemm's canal) cross-sectional area and volume", 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Correlation of changes with intraocular pressure (IOP) reduction', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma', 'Cataract']}, 'descriptionModule': {'briefSummary': "The purpose of our current series of studies is to evaluate different glaucoma treatments in vivo effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy using Enhanced Depth Imaging (EDI)-optical coherence tomography (OCT) . The images will be taken as part of the patients routine medical follow up (before starting the treatment, and 1,4 and 12 weeks afterwards) diameter, cross-sectional area and volume will be measured using commercially available 3-dimensional reconstruction.\n\nThe series of studies will be divided into 3 branches, each branch contains different treatments.For each treatment different patients will be recruited.\n\nThe branches are as following-\n\n1. The surgical branch-\n\n 1. Before and after trabeculotomy\n 2. Before and after cataract surgery\n 3. Before and after vitrectomy surgery\n 4. Before and after XEN™ Gel Stent implant\n2. The pharmacological branch-\n\n 1. Before and during the treatment with prostaglandins analogs\n 2. Before and during the treatment with alpha blockers\n 3. Before and during the treatment with beta blockers\n 4. Before and during the treatment with carbonic anhydrase inhibitor\n3. The laser branch-\n\n 1. Before and after trabeculoplasty\n 2. Before and after laser iridotomy\n 3. Before and after yag capsulotomy laser"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female of any race, at least 18 years of age.\n2. Has provided verbal and written informed consent.\n3. Able and willing to follow instructions, including participation in all study assessments and visits.\n4. Has been referred to one of the treatments mentioned\n\nExclusion Criteria:\n\n1. Has history of ocular conditions that may affect the SC structure (e.g., ocular neovascularization, anterior segment congenital anomalies)\n2. Subject uncooperativeness that restricts adequate examination of IOP, ocular fundus or\n3. any ocular or systemic conditions that may reduce OCT image quality (e.g., severe dry eye syndrome, visually significant cataract, limbal opacities, nystagmus, Parkinsonism, etc),\n4. Pregnant women or male or female younger than 18 years of age'}, 'identificationModule': {'nctId': 'NCT02807935', 'briefTitle': "The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal Micro-structure", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': "The in Vivo Effect of Medical and Surgical Glaucoma Treatments on the Schlemm's Canal", 'orgStudyIdInfo': {'id': 'SHEBA-16-2797-OZ-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'OCT imaging of surgical/pharmacological/laser branch', 'description': "to evaluate the effect on the conventional outflow pathway, and specifically on the Schlemm's canal (SC) anatomy in the surgical branch:\n\n1. Before and after trabeculotomy\n2. Before and after cataract surgery\n3. Before and after vitrectomy surgery\n4. Before and after XEN™ Gel Stent implant\n\npharmacological branch-\n\n1. Before and during the treatment with prostaglandins analogs\n2. Before and during the treatment with alpha blockers\n3. Before and during the treatment with beta blockers\n4. Before and during the treatment with carbonic anhydrase inhibitor\n\nlaser branch-\n\n1. Before and after trabeculoplasty\n2. Before and after laser iridotomy\n3. Before and after yag capsulotomy laser", 'interventionNames': ['Device: Optical coherence tomography imaging']}], 'interventions': [{'name': 'Optical coherence tomography imaging', 'type': 'DEVICE', 'armGroupLabels': ['OCT imaging of surgical/pharmacological/laser branch']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'miri fogel levin, m.d', 'role': 'CONTACT', 'email': 'mirifoglevin@gmail.com'}], 'facility': 'SHEBA medical center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'centralContacts': [{'name': 'Meira Fogel-Levin, M.D', 'role': 'CONTACT', 'email': 'mirifoglevin@gmail.com', 'phone': '972-523249402'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}