Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-31 @ 11:19 AM
Study NCT ID:
NCT06722794
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fixating the Plate of Ahmed Valve to the Sclera Using a Flanged Prolene Suture
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': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-12-06', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long term stability and plate migration', 'timeFrame': '3 months', 'description': 'ABSENT MOVEMENT OF THE PLATE WITH NO OTHER COMPLICATIONS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ahmed glaucoma valve, prolene, glaucoma drainage device'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma', 'detailedDescription': 'This technique of fixating Ahmed glaucoma valve using flanged prolene suture is an safe, fast, and reproducible technique combines the benefits of fixing the plate with excellent stability with no complications of free plate techniques at the same time, decreasing both the risks of old valve plate fixation techniques and the concerns of the relative technical difficulty'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with IOP more than 21 mmHg , evidence of progressive optic nerve damage, retinal nerve fiber layer defects or typical glaucomatous visual field defects despite maximal tolerable medical or laser treatment are scheduled for surgery.\n\nExclusion Criteria:\n\n* The exclusion criteria were as follows: patients below 18 years old, those with active uveitis and angle closure glaucoma patients.'}, 'identificationModule': {'nctId': 'NCT06722794', 'briefTitle': 'Fixating the Plate of Ahmed Valve to the Sclera Using a Flanged Prolene Suture', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture', 'orgStudyIdInfo': {'id': 'MEH-IRB# 310- 1-October-2024'}, 'secondaryIdInfos': [{'id': 'Maghrabi eye hospitals', 'type': 'OTHER', 'domain': 'Maghrabi eye hospitals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene S', 'description': 'Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture', 'interventionNames': ['Procedure: Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture']}], 'interventions': [{'name': 'Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture', 'type': 'PROCEDURE', 'description': 'This novel technique of fixating the plate of Ahmed glaucoma valve to the sclera using a single flanged prolene suture is an efficient, safe, fast, and reproducible technique that combines the benefits of both fixing the plate providing excellent stability without the complications of free plate techniques and at the same time, minimizing both the risks of conventional old valve plate fixation techniques and the concerns of the relative technical difficulty of suturing due to the difficult access to the posterior globe', 'armGroupLabels': ['Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22230', 'city': 'Jeddah', 'state': 'Jedda', 'country': 'Saudi Arabia', 'facility': 'Maghrabi Eye Hospitals', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}], 'overallOfficials': [{'name': 'AHMED SAMIR, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZAGAZIG UNIVERSITY AND MAGHRABI EYE HOSPITALS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'PERSONAL REASONS'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Magrabi Eye & Ear Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}