Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04635020
Status:
RECRUITING
Last Update Posted:
2020-11-18
First Post:
2020-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017889', 'term': 'Exfoliation Syndrome'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007499', 'term': 'Iris Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 285}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2033-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Group I and II: Number of patients with secondary glaucoma surgery', 'timeFrame': '10 years', 'description': 'Number of patients with secondary glaucoma surgery at 10 years from baseline is counted'}], 'primaryOutcomes': [{'measure': 'Group I: Change in the number of IOP lowering medications compared to baseline', 'timeFrame': '12 months', 'description': 'Accountability of IOP lowering medications used by the patient'}, {'measure': 'Group II: Change in the IOP compared to baseline', 'timeFrame': '12 months', 'description': 'IOP measured by Goldmann aplanation tonometry (GAT)'}], 'secondaryOutcomes': [{'measure': 'Group I: Change in the IOP compared to baseline', 'timeFrame': '12 months', 'description': 'IOP measured by GAT'}, {'measure': 'Group II: Change in the number of IOP lowering medications compared to baseline', 'timeFrame': '12 months', 'description': 'Accountability of IOP lowering medications used by the patient'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SLT', 'iStent'], 'conditions': ['Exfoliation Glaucoma', 'Cataract']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the efficacy of an iStent trabecular microbypass stent compared to selective laser trabeculoplasty in combination with cataract surgery in eyes with exfoliation glaucoma (EXF)', 'detailedDescription': 'Exfoliation glaucoma patients with significant cataracts are being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility for study entry. Patient´s glaucoma is classified into stable or unstable glaucoma groups with their current glaucoma medication. Patients meeting the eligibility requirements of stable glaucoma will be randomised to cataract surgery combined with iStent (65 patients), II SLT (65 patients) or III cataract surgery alone (25 patients) and patient with unstable glaucoma will be randomised to cataract surgery combined with I iStent (65 patients), II SLT (65 patients).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed consent of information\n* Clinical significant cataract\n* Able to attend 12 month period\n* Mild to moderate exfoliation glaucoma according to European glaucoma society guidelines (EGS)\n* Group I stable glaucoma (IOP within individual target IOP), and group II unstable glaucoma (IOP above individual target IOP) with baseline glaucoma medication\n* Target IOP ≥16\n* Able to understand Finnish, Swedish or English\n\nExclusion Criteria:\n\n* Clinical set target IOP \\< 16 mmHg in advanced glaucoma\n* Baseline IOP prior to enrolment ≥30 mmHg, and ≥3 glaucoma medications\n* Closed angle\n* Congenital angle anomaly\n* Clinically significant corneal dystrophy or other hindering corneal condition\n* Unable to use topical medical therapy\n* Central corneal thickness of less than 480um or more than 620um\n* Active uveitis, cystic macular edema (CME), exudative age-related macular degeneration, proliferative diabetic retinopathy or clinical significant macular edema, intraocular neoplasm, intraocular injections, intraocular lens luxation, phacodonesis.\n* Previous intraocular surgery, refractive surgery or cycloablation\n* Two or more prior SLT or laser trabeculoplasty\n* Unable to participate due to another medical disease or condition\n* Participating in another clinical trial'}, 'identificationModule': {'nctId': 'NCT04635020', 'acronym': 'COILEH', 'briefTitle': 'Comparison Of iStent to Laser in Exfoliation Glaucoma Helsinki Study Group', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'A Prospective Randomised Trial Comparing Selective Laser Trabeculoplasty (SLT) and iStent Trabecular Micro-bypass Stent Implantation Combined With Cataract Surgery in Exfoliation Glaucoma', 'orgStudyIdInfo': {'id': '123123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stable glaucoma iStent', 'description': 'Cataract surgery combined with iStent inject', 'interventionNames': ['Procedure: iStent', 'Procedure: Cataract surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Stable glaucoma SLT-laser', 'description': 'Cataract surgery combined with SLT-laser 1 month after surgery', 'interventionNames': ['Procedure: SLT-laser', 'Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stable glaucoma', 'description': 'Cataract surgery', 'interventionNames': ['Procedure: Cataract surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Unstable glaucoma iStent', 'description': 'Cataract surgery combined with iStent inject', 'interventionNames': ['Procedure: iStent', 'Procedure: Cataract surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Unstable glaucoma SLT-laser', 'description': 'Cataract surgery combined with SLT-laser 1 month after surgery', 'interventionNames': ['Procedure: SLT-laser', 'Procedure: Cataract surgery']}], 'interventions': [{'name': 'iStent', 'type': 'PROCEDURE', 'otherNames': ['Trabecular Micro-Bypass Stent System Model G2-M-IS, Glaukos Corporation, San Clemente, California'], 'description': '2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork', 'armGroupLabels': ['Stable glaucoma iStent', 'Unstable glaucoma iStent']}, {'name': 'SLT-laser', 'type': 'PROCEDURE', 'otherNames': ['Selective laser trabeculoplasty'], 'description': '1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)', 'armGroupLabels': ['Stable glaucoma SLT-laser', 'Unstable glaucoma SLT-laser']}, {'name': 'Cataract surgery', 'type': 'PROCEDURE', 'description': 'Conventional cataract surgery', 'armGroupLabels': ['Stable glaucoma', 'Stable glaucoma SLT-laser', 'Stable glaucoma iStent', 'Unstable glaucoma SLT-laser', 'Unstable glaucoma iStent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Eeva Ojanen, MD', 'role': 'CONTACT', 'email': 'eeva.ojanen@hus.fi', 'phone': '+358 503608589'}, {'name': 'Mika Harju, MD prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Eeva Ojanen, MD', 'role': 'CONTACT', 'email': 'eeva.ojanen@hus.fi', 'phone': '+358503608589'}], 'overallOfficials': [{'name': 'Mika Harju, MD, prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, professor', 'investigatorFullName': 'Prof. Mika Harju', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}