Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-25 @ 4:37 PM
Study NCT ID:
NCT07303257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2025-12-11', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).', 'timeFrame': 'Pre-operative period and 6 months after intervention', 'description': 'To evaluate, in adult patients undergoing glaucoma surgery, the change in NEI-VFQ 25 quality of life score between the pre-operative period and 6ᵉ months post-operatively, for the different surgical techniques cited.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Trabeculectomy', 'Non-penetrating deep sclerectomy', 'PreserFlo®', 'Quality of life'], 'conditions': ['Glaucoma Eye']}, 'descriptionModule': {'briefSummary': "Glaucoma, the leading cause of irreversible blindness, affects more than 60 million people worldwide and 1.3 million in France. Its treatment aims to reduce intraocular pressure, in particular by surgery when eye drops and laser treatment are insufficient.\n\nConventional filtering techniques and MIGS (Minimally Invasive Glaucoma Surgery), including PreserFlo® MicroShunt, pursue the same objective in terms of blood pressure, but differ in terms of their post-operative profile and tolerability.\n\nExisting studies show similar quality of life scores between filtering and MIGS surgeries. However, no direct comparison has yet been made between trabeculectomy, non-penetrating deep sclerectomy and PreserFlo® at 3 and 6 months, making it pertinent to assess their respective effects on patients' quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged ≥ 18 years with indication for surgical treatment\n* Interventions: Preserflo, Trabeculectomy and non-penetrating deep sclerectomy\n* Beginning, moderate and severe uni or bilateral open or closed angle glaucoma\n* Pseudoxexfoliative or pigmentary glaucoma\n* Patient with consent to participate in research\n\nExclusion Criteria:\n\n* Secondary causes of glaucoma: uveitic glaucoma, cortisone-induced glaucoma, traumatic glaucoma\n* Congenital glaucoma\n* Multi-operated refractory glaucoma\n* Ophthalmological surgery within 6 months of inclusion\n* Severe visual co-morbidities (age-related macular degeneration, severe diabetic retinopathy, retinal degeneration, etc.)\n* Difficulty in organising follow-up (foreseeable poor cooperation from the patient, planned travel or absence during follow-up)\n* Patient illiterate, unable to speak French or with impaired cognitive ability\n* Patients with a significant pre-existing impairment in quality of life attributable to a progressive physical pathology or neuropsychiatric disorder.\n* Patients under curatorship or guardianship\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT07303257', 'acronym': 'G-SCOPE', 'briefTitle': 'Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options - G-SCOPE (Glaucoma Surgery - Comparative Patient Evaluation)', 'orgStudyIdInfo': {'id': '69HCL25_0896'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Preserflo', 'description': 'Designed to treat primary open-angle glaucoma, PRESERFLO™ MicroShunt is a tiny, soft, flexible stent that helps your eye drain excess fluid, and may help lower eye pressure and prevent further vision loss.', 'interventionNames': ['Procedure: Preserflo']}, {'type': 'OTHER', 'label': 'Trabeculectomy', 'description': 'Trabeculectomy is an operation which helps to drain fluid out of the eye and into a small blister (called a bleb) under the surface of the eye (the conjunctiva). The operation creates a kind of trap door for the fluid to pass through, bypassing the normal drainage channel. Drainage of aqueous is improved and this reduces intraocular pressure (IOP).', 'interventionNames': ['Procedure: Trabeculectomy']}, {'type': 'OTHER', 'label': 'Non-penetrating deep sclerectomy', 'description': "Non-penetrating deep sclerectomy (NPDS) is a filtering surgery where the internal wall of Schlemm's canal is excised, allowing sub-conjunctival filtration without actually entering the anterior chamber. This technique was developed to minimize the complications of trabeculectomy", 'interventionNames': ['Procedure: Non-penetrating deep sclerectomy']}], 'interventions': [{'name': 'Preserflo', 'type': 'PROCEDURE', 'description': 'Designed to treat primary open-angle glaucoma, PRESERFLO™ MicroShunt is a tiny, soft, flexible stent that helps your eye drain excess fluid, and may help lower eye pressure and prevent further vision loss.', 'armGroupLabels': ['Preserflo']}, {'name': 'Trabeculectomy', 'type': 'PROCEDURE', 'description': 'Trabeculectomy is an operation which helps to drain fluid out of the eye and into a small blister (called a bleb) under the surface of the eye (the conjunctiva). The operation creates a kind of trap door for the fluid to pass through, bypassing the normal drainage channel. Drainage of aqueous is improved and this reduces intraocular pressure (IOP).', 'armGroupLabels': ['Trabeculectomy']}, {'name': 'Non-penetrating deep sclerectomy', 'type': 'PROCEDURE', 'description': "Non-penetrating deep sclerectomy (NPDS) is a filtering surgery where the internal wall of Schlemm's canal is excised, allowing sub-conjunctival filtration without actually entering the anterior chamber. This technique was developed to minimize the complications of trabeculectomy.", 'armGroupLabels': ['Non-penetrating deep sclerectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69317', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Victor VERMOT-DESROCHES, MD', 'role': 'CONTACT'}, {'name': 'Victor VERMOT-DESROCHES, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Victor VERMOT-DESROCHES, MD', 'role': 'CONTACT', 'email': 'victor.vermot-desroches@chu-lyon.fr', 'phone': '684 019 303', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}