Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT05576493
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2022-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2022-10-08', 'studyFirstSubmitQcDate': '2022-10-08', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of intraocular pressure change', 'timeFrame': '6 Months', 'description': 'measuring the intraocular pressure after 1M, 3M and 6M'}], 'secondaryOutcomes': [{'measure': 'percent change of antiglaucoma medications', 'timeFrame': '6 Months', 'description': 'the number of medication before and after the procedure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['angle closure glaucoma', 'cyclophotocoagulation'], 'conditions': ['Angle Closure Glaucoma']}, 'descriptionModule': {'briefSummary': 'comparing different types of cuclophotocoagulation with cataract extraction to cataract extraction and goniocynechiolysis in cases of chronic angle closure glaucoma', 'detailedDescription': 'Evaluation of the safety of MP-TSCPC , CW-TSCPC and endoscopic cyclophotocoagulation when combined with phacoemulsification in cases with CACG Comparing the efficacy of the combined procedures in control of the IOP and the success rate versus lens extraction combined with synechiolysis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 20 to 70 years\n\nchronic angle closure glaucoma\n\nExclusion Criteria:\n\n* Patients in acute attack of angle closure.\n* Patients with previous filtering surgery or cycloablative procedure'}, 'identificationModule': {'nctId': 'NCT05576493', 'briefTitle': 'Combined Phacoemulsification and Diode Laser Therapy in Chronic Angle Closure Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Combined Phacoemulsification and Different Modes of Diode Laser Therapy in Management of Chronic Angle Closure Glaucoma. A Comparative Study', 'orgStudyIdInfo': {'id': 'N-68-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A:phaco+MP-TSCPC', 'description': '22 patients with primary angle closure glaucoma will undergo phacoemulsification and micropulse cyclophotocoagulation', 'interventionNames': ['Procedure: phaco+MP-TSCPC']}, {'type': 'EXPERIMENTAL', 'label': 'B:phaco+TSCPC', 'description': '22 patients with primary angle closure glaucoma will undergo phaco and transscleral cyclophotocoagulation', 'interventionNames': ['Procedure: phaco+TSCPC']}, {'type': 'EXPERIMENTAL', 'label': 'C:phaco+endocyclophotocoagulation', 'description': '22 patients with primary angle closure glaucoma will undergo phaco and endocyclophotocoagulation after cataract removal', 'interventionNames': ['Procedure: phaco+endocyclophotocoagulation']}, {'type': 'EXPERIMENTAL', 'label': 'D:phaco GSL', 'description': '22 patients with primary angle closure glaucoma will undergo phaco and goniosynechiolysis', 'interventionNames': ['Procedure: phaco GSL']}], 'interventions': [{'name': 'phaco+MP-TSCPC', 'type': 'PROCEDURE', 'description': 'The procedure starts with performing the cyclophotocoagulation using the Micropulse P3 device (IQ 810 Laser Systems; Iridex, Mountain View, CA, USA) at 2500 mW with a duration of 90 seconds in each hemisphere at a 31.3% duty cycle under local anesthesia and then performing phacoemulsification and IOL implantation.', 'armGroupLabels': ['A:phaco+MP-TSCPC']}, {'name': 'phaco+TSCPC', 'type': 'PROCEDURE', 'description': "The procedure starts with performing the cyclophotocoagulation using the IRIDEX's G probe device (IRIDEX Corp. Mountain View, CA, USA) at 1500 to2000 mW with a duration of 1500 ms applying about 15 shots in one hemisphere only under local anesthesia and then performing phacoemulsification and IOL implantation.", 'armGroupLabels': ['B:phaco+TSCPC']}, {'name': 'phaco+endocyclophotocoagulation', 'type': 'PROCEDURE', 'description': 'phacoemulsification will be done and endocyclophotocoagulation will be done after cataract extraction', 'armGroupLabels': ['C:phaco+endocyclophotocoagulation']}, {'name': 'phaco GSL', 'type': 'PROCEDURE', 'description': 'phacoemulsification will be done and then the angle is visualized by direct goniolens then the synechia are dissected by cohesive viscoelastic.', 'armGroupLabels': ['D:phaco GSL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Abdelrahman, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'kasr alainy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Fayrouz Aboalazayem', 'investigatorAffiliation': 'Cairo University'}}}}