Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 4:08 PM
Study NCT ID:
NCT00971061
Status:
COMPLETED
Last Update Posted:
2009-09-04
First Post:
2009-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-03', 'studyFirstSubmitDate': '2009-09-02', 'studyFirstSubmitQcDate': '2009-09-02', 'lastUpdatePostDateStruct': {'date': '2009-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra Ocular pressure (IOP)', 'timeFrame': 'Month 24'}], 'secondaryOutcomes': [{'measure': 'Intra Ocular pressure (IOP)', 'timeFrame': 'day 1,week 1, and months 1, 3, 6, 9, 12 and 18'}, {'measure': 'Changes in visual acuity', 'timeFrame': 'day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24.'}, {'measure': 'Number of anti-glaucoma medications', 'timeFrame': 'week 1, and months 1, 3, 6, 9, 12, 18, and 24'}, {'measure': 'Mean deviation of visual field,', 'timeFrame': 'week 1, and months 1, 3, 6, 9, 12, 18, and 24'}, {'measure': 'Rate of intra- and postoperative complications', 'timeFrame': 'week 1, and months 1, 3, 6, 9, 12, 18, and 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ahmed valve', 'single-plate Molteno implant', 'refractory glaucoma', 'surgical treatment'], 'conditions': ['Refractory Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof.\n\nExclusion Criteria:\n\n* age less than 40 years\n* a visual acuity of no light perception\n* lens opacity\n* elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye\n* previous cyclodestructive treatment\n* increased risk of endophthalmitis posterior segment disorders\n* pre-existing ocular comorbidities.'}, 'identificationModule': {'nctId': 'NCT00971061', 'briefTitle': 'Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Vanak Eye Surgery Center'}, 'orgStudyIdInfo': {'id': '1465087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSPI', 'description': 'Molteno single-plate implant', 'interventionNames': ['Device: Molteno single-plate implant (MSPI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AVI', 'description': 'Ahmed valve implant', 'interventionNames': ['Device: Ahmed valve implant']}], 'interventions': [{'name': 'Ahmed valve implant', 'type': 'DEVICE', 'description': '184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)', 'armGroupLabels': ['AVI']}, {'name': 'Molteno single-plate implant (MSPI)', 'type': 'DEVICE', 'description': '134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)', 'armGroupLabels': ['MSPI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Vanak Eye Surgery Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Nader Nassiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran'}, {'name': 'Nariman Nassiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Researcher, Vanak Eye Surgery Center, Tehran, Iran'}, {'name': 'Ghazal Kamali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '4th-year Resident, Department of Ophthalmology, Imam Hussein Medical Center, Shaheed Beheshti University of Medical Sciences, Tehran, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanak Eye Surgery Center', 'class': 'OTHER'}}}}