Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-30 @ 5:15 AM
Study NCT ID:
NCT06445634
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of GATT Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015812', 'term': 'Glaucoma, Angle-Closure'}], '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', 'interventionModelDescription': 'prospective cohort'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-05', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IOP and glaucoma medications.', 'timeFrame': '1day,1 week,1 months, 3 months, 6 months and 1 year', 'description': 'measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative'}, {'measure': 'Surgical success.', 'timeFrame': '1day,1 week,1 months, 3 months, 6 months and 1 year', 'description': 'Surgical success will be defined as: complete if IOP is less than or equal to 21mmHg without medications and qualified success if IOP is less than or equal to 21mmHg with medications. Failure will be the inability to achieve such a pressure, the need for another glaucoma operation or the development of a sight-threatening complication (e.g., retinal detachment, endophthalmitis)'}], 'secondaryOutcomes': [{'measure': 'Complications.', 'timeFrame': '1day,1 week,1 months, 3 months, 6 months and 1 year', 'description': 'rate of complications will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['secodary angle closure', 'GATT', 'intra ocular pressure'], 'conditions': ['Glaucoma, Angle-Closure']}, 'descriptionModule': {'briefSummary': 'To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.', 'detailedDescription': 'Glaucoma is a group of diseases that present with cupping of the optic nerve head and visual-field defects. It is the most common cause of irreversible blindness all over the world.Angle-closure glaucoma is a type of glaucoma characterized by narrowing or closure of the anterior chamber angle.\n\nTwo major types of angle closure glaucoma are defined by the mechanism of angle closure: in appositional contact, the iris is pushed by a pressure difference between the posterior and anterior chambers due to relative pupillary block, while in synechial contact, the peripheral iris adheres to the trabecular meshwork by peripheral anterior synechiae (PAS). PAS can develop in various ocular conditions, including: ocular inflammation, a post-traumatic condition, after cataract surgery, or with an iris bombe in a pupillary block glaucoma.\n\nGrover et al. described a technique for ab-Interno circumferential trabeculotomy termed gonioscopy-assisted transluminal trabeculotomy (GATT). The procedure aims to create a 360° trabeculotomy from an ab-Interno approach.\n\nGATT procedure is a MIGS technique in which trabecular meshwork is circumferentially bypassed by incising it using a suture or microcatheter.In this technique, aqueous humor passes through the collector channels and episcleral veins through the cleaved open diseased trabecular meshwork.\n\nElsayed et al previously demonstrated that combining phacoemulsification with GATT in PACG yielded more favorable outcomes in terms of IOP, glaucoma medications and surgical success compared to phacoemulsification alone.However, to date, no studies have looked at the outcomes of combining goniosynechialysis with GATT in secondary angle closure glaucoma. In fact, most studies looking at the outcomes of GATT in different types of glaucoma excluded eyes with synechial angle closure.\n\nGoniosynechialysis (GSL) is the process of physically separating PAS, which can develop in the trabecular meshwork due to various conditions including primary and secondary cases of angle closure.\n\nSo, for those cases of synechial angle closure glaucoma combining GATT and GSL might aid in the IOP lowering effect required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with secondary synechial angle closure glaucoma\n* Involving more than 180 degrees of the iridocorneal angle\n* Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.\n\nExclusion Criteria:\n\n* Eyes with PACG.\n* Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).\n* Eyes with retinal pathology.\n* Eyes requiring combined phacoemulsification and GATT.\n* Eyes with corneal pathology that can preclude surgery and imaging.'}, 'identificationModule': {'nctId': 'NCT06445634', 'briefTitle': 'Outcome of GATT Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure.', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure: A Prospective Case Series', 'orgStudyIdInfo': {'id': '_MD-393-2023_'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Gatt combined with goinosynechiolysis in secondary synechial angle closure', 'description': 'Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure', 'interventionNames': ['Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis']}], 'interventions': [{'name': 'Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis', 'type': 'OTHER', 'otherNames': ['GATT'], 'description': 'Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure', 'armGroupLabels': ['Gatt combined with goinosynechiolysis in secondary synechial angle closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11555', 'city': 'Giza', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rokaya Radwan', 'role': 'CONTACT', 'email': 'rokaia.e.radwan@students.kasralainy.edu.eg', 'phone': '01066471468', 'phoneExt': '+2'}], 'facility': 'Kasralainy Hospitals', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Rokaya Radwan', 'role': 'CONTACT', 'email': 'rokaia.e.radwan@students.kasralainy.edu.eg', 'phone': '01066471468', 'phoneExt': '+2'}, {'name': 'Fayrouz Aboalazaym', 'role': 'CONTACT', 'email': 'fayrouzaboalazaym@gmail.com', 'phone': '01007419500', 'phoneExt': '+2'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After publication within 18 months', 'ipdSharing': 'YES', 'description': 'medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data', 'accessCriteria': 'will be uploaded'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Rokaya Emad Radwan', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}