Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2025-12-30 @ 2:02 PM
Study NCT ID:
NCT01212861
Status:
COMPLETED
Last Update Posted:
2012-09-12
First Post:
2010-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Refractory Open Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-11', 'studyFirstSubmitDate': '2010-09-29', 'studyFirstSubmitQcDate': '2010-09-30', 'lastUpdatePostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative intraocular pressure, glaucoma medication usage, and visual acuity', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': "The primary objective of this study is to evaluate the safety, efficacy, and performance of the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and the suprachoroidal space in refractory, open angle glaucoma subjects.", 'detailedDescription': "The Suprachoroidal Dissection Instrument (SDI) is a manually operated surgical instrument designed for use within Schlemm's canal. The instrument can access Schlemm's canal through a small ab-externo dissection, allowing use in eyes with scarring due to previous surgery or trauma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Available for up to 3 years follow-up.\n* Diagnosed with primary open-angle, pseudoexfoliative, or pigmentary glaucoma or more than one glaucoma diagnosis of these types.\n* Subject scheduled to undergo glaucoma surgery with the Suprachoroidal Dissection Instrument involving creation of fistula between Schlemm's canal and the suprachoroidal space without combined cataract surgery.\n* Subject has failed at least one incisional glaucoma surgery (trabeculectomy, tube shunt, deep sclerectomy, viscocanalostomy, canaloplasty) or angle surgery (Trabectome) OR Is not a candidate for conventional glaucoma surgery due to reasons such as the presence of scleral buckle or compromised conjunctiva.\n* Subject has IOP ≥ 16 mm Hg on maximally tolerated medications within the six week (-42 days) period prior to surgery.\n* Visual field defect defined as mean deviation (MD) score worse than or equal to -10 dB on the Swedish Interactive Threshold Algorithm \\[SITA\\] Standard 24-2 Humphrey Analysis during the 6 month period prior to surgery. OR Subject has vertical cup-to-disk ratio ≥ 0.75 during the 6 month period prior to surgery.\n\nExclusion Criteria:\n\n* Significant lens opacities or patient is candidate for cataract surgery during the duration of the study.\n* The patient had developmental glaucoma or a secondary glaucoma including steroid-induced, uveitic, or neovascular glaucoma (with the exception of pigmentary and pseudoexfoliative glaucoma).\n* The patient has narrow angle component possibly associated with glaucoma in the operative eye.\n* The subject has angle recession in the operative eye.\n* Significant ocular disease other than glaucoma affecting the assessment of visual function."}, 'identificationModule': {'nctId': 'NCT01212861', 'briefTitle': 'Surgical Treatment of Refractory Open Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'iScience Interventional Corporation'}, 'officialTitle': 'Surgical Treatment of Refractory Open Angle Glaucoma - A Prospective, Open-Label, Pilot Study', 'orgStudyIdInfo': {'id': '060410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suprachoroidal Dissection Instrument', 'interventionNames': ['Device: Suprachoroidal Dissection Instrument (SDI)']}], 'interventions': [{'name': 'Suprachoroidal Dissection Instrument (SDI)', 'type': 'DEVICE', 'otherNames': ['SDI'], 'description': "The Suprachoroidal Dissection Instrument (SDI) is a manually operated, non-powered, re-usable ophthalmic surgical instrument. The SDI is designed to enter a surgically exposed Schlemm's canal and be advanced up to 90 degrees around the canal from the entry site.", 'armGroupLabels': ['Suprachoroidal Dissection Instrument']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaucoma Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Ronald Fellman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glaucoma Associates of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iScience Interventional Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}