Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-28 @ 4:28 PM
Study NCT ID:
NCT01468103
Status:
UNKNOWN
Last Update Posted:
2011-11-09
First Post:
2011-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-08', 'studyFirstSubmitDate': '2011-11-06', 'studyFirstSubmitQcDate': '2011-11-08', 'lastUpdatePostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraocular pressure', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Angle assessment parameters', 'timeFrame': '3 years', 'description': 'Angle assessment parameters,such as anterior chamber openning distance,are acquired by anterior segment optical coherence tomography.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraocular pressure', 'Peripheral anterior synechiae'], 'conditions': ['Intraocular Pressure Changes', 'Peripheral Anterior Synechiae Increasing']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled clinical trial to compare laser peripheral iridotomy(LPI) and surgical peripheral iridectomy. Subjects of primary angle closure suspect, primary angle closure will be randomized to undergo LPI or SPI. Subjects are proposed to be followed up for 3 years.', 'detailedDescription': 'The following will be studied:\n\n1. To evaluate the safety of these two techniques for the treatment of angle closure.\n2. To compare the anterior chamber reaction and IOP changes post surgery.\n3. TO establish the UBM/ASOCT chamber angle parameters changes pre and post surgery.\n4. To assess the development of PAS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. more than 50 years old\n2. Diagnosis of either: Primary angle closure suspects, Primary angle closure in need of laser iridotomy or surgical iridectomy\n3. Able to give Informed concent\n\nExclusion Criteria:\n\n1. Ophthalmic diseases other than glaucoma and cataract\n2. pseudophakic or aphakic patients\n3. inability to attend regular follow-up assessment or to give informed written consent\n4. Secondary causes of angle closure e.g. subluxed lens, uveitis, trauma and neovascular glaucoma\n5. Participating in another study\n6. monocular patients'}, 'identificationModule': {'nctId': 'NCT01468103', 'briefTitle': 'Laser Iridotomy Versus Surgical Iridectomy in Early Angle Closure', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Laser Peripheral Iridotomy Versus Surgical Peripheral Iridectomy in Early Angle Closure:a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '19831105gaoxinbo'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PACS', 'description': 'primary angle closure suspects', 'interventionNames': ['Procedure: Surgical Iridectomy', 'Procedure: Laser Iridotomy']}, {'type': 'EXPERIMENTAL', 'label': 'PAC', 'description': 'primary angle closure', 'interventionNames': ['Procedure: Surgical Iridectomy', 'Procedure: Laser Iridotomy']}], 'interventions': [{'name': 'Surgical Iridectomy', 'type': 'PROCEDURE', 'otherNames': ['Peripheral Surgical Iridectomy'], 'description': 'Surgical Iridectomy is now widely used in our clinical.', 'armGroupLabels': ['PAC', 'PACS']}, {'name': 'Laser Iridotomy', 'type': 'PROCEDURE', 'otherNames': ['Peripheral Laser Iridotomy'], 'description': 'alternative choice to surgical iridectomy', 'armGroupLabels': ['PAC', 'PACS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gao Xinbo, MD', 'role': 'CONTACT', 'email': 'ice.freeport@163.com'}, {'name': 'Gao Xinbo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ZhongShan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zhang X Lan, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'student', 'investigatorFullName': 'Gao Xinbo', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}