Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT06213805
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'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': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-01-10', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of intraocular pressure by tonometry', 'timeFrame': 'day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery', 'description': 'Measure in millimeters of mercury (mmHg)'}], 'secondaryOutcomes': [{'measure': 'visual quality of life VFQ-25,', 'timeFrame': 'month 1, month 3, month 12 after surgery', 'description': '25 questions about visual quality of life with Likert scale (1-5 and 1-6)'}, {'measure': 'Optical Coherence Tomography', 'timeFrame': 'month 3, month 12', 'description': 'high-resolution images of the retina and anterior segment'}, {'measure': 'Visual field test', 'timeFrame': 'month 3, month 12', 'description': 'Measure of visual field in degree (°)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years old who agree to participate in the study having signed informed consent\n* Primary open-angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma with indication for glaucoma surgery (defined as uncontrolled intraocular pressure or worsening of visual fields, despite maximum tolerated medical therapy) and open iridocorneal angle ( trabecular meshwork visible on gonioscopy, Shaffer classification grade 3-4) and healthy and mobile conjunctiva (without scars or adhesions).\n* Chronic angle closure glaucoma with indication for combined glaucoma and cataract surgery\n\nExclusion Criteria:\n\n* Presence of other ophthalmological pathologies (except cataract)\n* History of intraocular surgery (unless cataract surgery), history of trauma, or conjunctival scarring in the quadrant planned for surgery\n* Visual acuity lower than "counts fingers" ", closure of the iridocorneal angle (and angle-closure glaucoma unless associated cataract surgery), neovascular glaucoma or neovascularization of the iris, pachymetry \\< 490 μm or \\> 620 μm.\n* Presence of severe systemic pathologies, pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT06213805', 'acronym': 'MIMS', 'briefTitle': 'Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Privé de la Baie'}, 'officialTitle': 'Efficacy and Safety of Minimally Invasive Micro-Sclerostomy (MIMS) in Glaucoma Surgery', 'orgStudyIdInfo': {'id': '2023-A02193-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minimally invasive microsclerostomy', 'interventionNames': ['Procedure: Minimally invasive microsclerostomy']}], 'interventions': [{'name': 'Minimally invasive microsclerostomy', 'type': 'PROCEDURE', 'description': 'MIMS is a filtering glaucoma surgery, which consists of creating a sclero-corneal drainage channel, to allow the flow of aqueous humor and therefore the reduction of intraocular pressure.\n\nThis surgery is extremely quick, lasting 3 to 5 minutes, according to recent MIMS studies, in contrast to the duration of a trabeculectomy, the classic glaucoma surgery, which varies between 20 and 60 minutes.', 'armGroupLabels': ['Minimally invasive microsclerostomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50300', 'city': 'Avranches', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ana Miguel, MD', 'role': 'CONTACT', 'email': 'myworld_ana@hotmail.com', 'phone': '+33(0)787016187'}], 'facility': 'Hôpital Privé de la Baie', 'geoPoint': {'lat': 48.68436, 'lon': -1.35686}}, {'zip': '33100', 'city': 'Bordeaux', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Clinique Thiers', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75019', 'city': 'Paris', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Fondation Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Ana Miguel, MD', 'role': 'CONTACT', 'email': 'myworld_ana@hotmail.com', 'phone': '+33787016187'}], 'overallOfficials': [{'name': 'Ana Miguel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Privé de la Baie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Privé de la Baie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}