Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT05035394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-05
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Swedish Microinvasive Glaucoma Surgery Study (SMIGS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007905', 'term': 'Lens Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-18', 'size': 375235, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-26T23:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants that need further surgery', 'timeFrame': '12 to 24 months', 'description': 'Arm comparison of future need for microinvasive surgery, filtering surgery or cyclodestructive laser'}, {'measure': 'Number of participants that need additional medical therapy', 'timeFrame': '12 to 24 months', 'description': 'Assessment of the need for future medical therapy in the study groups'}], 'primaryOutcomes': [{'measure': 'Change in the number of intraocular pressure lowering medications compared to baseline', 'timeFrame': '12 to 24 months', 'description': 'Accountability of intraocular pressure lowering medications used by the patient'}, {'measure': 'Number of participants with ≥20 percent intraocular pressure reduction or reduction with ≥1 medication compared to baseline', 'timeFrame': '12 to 24 months', 'description': 'Intraocular pressure measured by Goldmann applanation tonometry (GAT)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with intraocular pressure ≤21 mm Hg, ≤18 mm Hg, ≤15 mm Hg and ≤12mm Hg', 'timeFrame': '12 to 24 months', 'description': 'Intraocular pressure measured by Goldmann applanation tonometry (GAT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma', 'Cataract', 'Kahook Dual Blade Glide', 'Istent Inject W', 'MIGS', 'Goniotomy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate the efficacy of Cataract Surgery as stand-alone compared to Cataract Surgery in combination with Kahook Dual Blade Glide goniotomy (KDB) or iStent Inject W Trabecular Microbypass Stent (Istent) in eyes with Open-angle glaucoma.', 'detailedDescription': 'Glaucoma patients with significant cataract are being informed about the study and potential risks, all participants giving written informed consent and meeting the criteria will become eligibility for study entry. Participants meeting the eligible requirements will be randomized to Cataract Surgery as stand-alone (40 patients) or Cataract Surgery combined with Kahook Dual Blade Glide (40 patients) or iStent Inject W (40 patients).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only one eye per participant\n* Clinically significant cataract\n* Glaucoma or intraocular hypertension treated with one to four medications and no need for filtering glaucoma surgery at the time of study enrollment.\n* Open chamber angle with Schaffer grading three to four in at least two quadrants\n\nExclusion Criteria:\n\n* Previous glaucoma surgery, including cyclodestructive procedures.\n* Selective Laser Trabeculoplasty (SLT) within 90 days prior to planned surgery.\n* Exudative age-related macular degeneration, proliferative diabetic retinopathy, clinically significant corneal dystrophy, other eye disease that affect intraocular eye pressure or visual field.\n* Unable to participate and make written consent due to another medical condition.'}, 'identificationModule': {'nctId': 'NCT05035394', 'acronym': 'SMIGS', 'briefTitle': 'Swedish Microinvasive Glaucoma Surgery Study (SMIGS)', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'A Prospective Randomized Trial Comparing Cataract Surgery as Stand Alone and Cataract Surgery Combined With Kahook Dual Blade Glide Goniotomy or Istent Inject W Trabecular Micro-Bypass Stent in Open-Angle Glaucoma.', 'orgStudyIdInfo': {'id': '2021-02970'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cataract surgery as stand alone', 'description': 'Cataract surgery as stand alone. Cataract surgery will be performed in a standardized fashion.', 'interventionNames': ['Procedure: Cataract surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cataract surgery in combination with Kahook Dual Blade glide goniotomy', 'description': 'Cataract surgery combined with Kahook Dual Blade Glide goniotomy. The goniotomy will be performed at the end of cataract surgery through the temporal cataract incision.', 'interventionNames': ['Procedure: KDB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cataract surgery in combination with iStent Inject W implantation', 'description': 'Cataract surgery combined with iStent Inject W. The two stents will be injected in Schlemms canal at the end of cataract surgery through the temporal cataract incision.', 'interventionNames': ['Procedure: Istent']}], 'interventions': [{'name': 'Cataract surgery', 'type': 'PROCEDURE', 'otherNames': ['Phacoemulsification', 'Cataract Surgery as stand-alone'], 'description': 'Cataract Surgery in a standardized fashion', 'armGroupLabels': ['Cataract surgery as stand alone']}, {'name': 'KDB', 'type': 'PROCEDURE', 'otherNames': ['Kahook Dual Blade Glide, New World Medical, Inc, Rancho Cucamonga, CA', 'KDB glide'], 'description': 'Goniotomy with KDB glide will be performed at the end of Cataract Surgery', 'armGroupLabels': ['Cataract surgery in combination with Kahook Dual Blade glide goniotomy']}, {'name': 'Istent', 'type': 'PROCEDURE', 'otherNames': ['iStent inject W', 'Trabecular Micro-Bypass Stent System Model G2-W, Glaukos Corporation, San Clemente, California'], 'description': 'Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery', 'armGroupLabels': ['Cataract surgery in combination with iStent Inject W implantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83183', 'city': 'Östersund', 'state': 'Östersund', 'country': 'Sweden', 'facility': 'Eye clinic at the hospital of Ostersund', 'geoPoint': {'lat': 63.1792, 'lon': 14.63566}}], 'overallOfficials': [{'name': 'Anna Barkander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of Ostersund, department of Ophtalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anna Barkander', 'investigatorAffiliation': 'Umeå University'}}}}