Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-25 @ 4:19 PM
Study NCT ID:
NCT04172857
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2019-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Malignant Glaucoma by Anterior Vitrectomy From Two Different Approaches
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D032801', 'term': 'Iridectomy'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-19', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relapse of MG', 'timeFrame': 'follow up: 3 to 31 months', 'description': 'MG relapse after the anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glaucoma Secondary']}, 'referencesModule': {'references': [{'pmid': '32280517', 'type': 'DERIVED', 'citation': 'Qian Z, Chan YK, Wei L, Zheng B, Nie L, Pan W. Evaluation of Two Different Anterior Vitrectomies for Fluid Misdirection Syndrome Secondary to Cataract Surgery Combined with Goniosynechialysis. J Ophthalmol. 2020 Mar 23;2020:1934086. doi: 10.1155/2020/1934086. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'To compare the surgical outcomes of treating phacoemulsification with intraocular lens implantation combined with goniosynechialysis (Phaco-IOL-GSL) associated malignant glaucoma (MG), using different incision sites in anterior vitrectomy combined with hyaloidotomy, zonulectomy, and iridectomy (VHZI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The medical records of all patients who developed clinical evidence of MG after Phaco-IOL-GSL, at the Affiliated Eye Hospital of Wenzhou Medical University from May 2015 to February 2018, were reviewed.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MG was diagnosed based on the presence of a central and peripheral shallow anterior chamber with normal or elevated intraocular pressure (IOP).\n\nExclusion Criteria:\n\n* The diagnosis was made only after confirming the absence of choroidal detachment or hemorrhage and posterior segment mass lesion, using B-scan ultrasonography or ophthalmoscopy'}, 'identificationModule': {'nctId': 'NCT04172857', 'briefTitle': 'Treatment of Malignant Glaucoma by Anterior Vitrectomy From Two Different Approaches', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Treatment of Malignant Glaucoma Secondary to Cataract Surgery Combined With Goniosynechialysis by Anterior Vitrectomy From Two Different Approaches', 'orgStudyIdInfo': {'id': 'QZB-MG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomy', 'type': 'PROCEDURE', 'description': 'First, a 23-G incision was made at the peripheral inferior temporal sector of the cornea and connected with an anterior chamber infusion cannula. Another corneal incision was made at the superior temporal sector or superior nasal sector, and Viscoat® (Bausch \\& Lomb, Shandong, China) was infused though the incision to fill the anterior chamber. Iridotomy was performed through the incision using Wescott scissors and toothed forceps. Hyaloidectomy and zonulectomy were performed through a peripheral iris defect using an anterior chamber approach to set up a pathway between the anterior chamber and the vitreous cavity. We repeatedly carried out vitrectomy around the pathway to reduce the risk of postoperative re-obstruction of the tunnel created.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher；clinical research center', 'investigatorFullName': 'yin ying zhao', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}