Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT03610295
Status:
COMPLETED
Last Update Posted:
2019-03-12
First Post:
2018-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}], 'ancestors': [{'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Retrospective,consecutive,nonrandomized comparative trial with historical control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-09', 'studyFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2018-07-31', 'lastUpdatePostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of aphakic angle-closure glaucoma', 'timeFrame': '18-49 months', 'description': 'Pupillary block with subsequent closure of the filtration angle is the cause of early aphakic angle-closure glaucoma (AACG), which usually happens in the early postoperative period, generally within the first 6 months. AACG presents with elevated IOP (repeatedly \\>25 mmHg), corneal edema, iris bombe, shallow anterior chamber, peripheral anterior synechia and angle closure.'}], 'secondaryOutcomes': [{'measure': 'The rate of iris posterior synechia', 'timeFrame': '18-49 months', 'description': 'Postoperative uveal inflammation can result in iris posterior synechia (IPS), referring to the synechia between iris and capsule around pupil. IPS is graded according to the range of the synechia. Grade 0: no synechia; Grade I: \\<1 quadrant; Grade II: ≤2 quadrants and \\>1 quadrant ; Grade III: ≤3 quadrants and \\>2 quadrants; Grade IV: \\>3 quadrants.'}, {'measure': 'The rate of visual axis opacity', 'timeFrame': '18-49 months', 'description': 'visual axis opacification (VAO) refers to developing reopacification of the visual axis in the form of lens proliferation into the visual axis or pupillary membrane.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital cataract', 'prophylactic peripheral iridectomy', 'aphakic angle-closure glaucoma', 'aphakic open-angle glaucoma', 'iris posterior synechia', 'visual axis opacity'], 'conditions': ['Congenital Cataract', 'Aphakic Glaucoma']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, nonrandomized comparative trial with historical control to investigate the safety and efficacy of a novel progressive grasping peripheral iridectomy (PGPI) surgical method in preventing aphakic angle-closure glaucoma (AACG) following congenital cataract surgery.', 'detailedDescription': 'Aphakic angle-closure glaucoma (AACG) following congenital cataract surgery is a common and serious complication which can be prevented by prophylactic peripheral iridectomy (PPI). However, it is difficult to perform routine PPI via scleral tunnel incision especially when the pupil is dilated. Here, the investigators designed a novel progressive grasping peripheral iridectomy (PGPI) surgical method which can ensure the accurate iridectomy position and minimize the complication. The aim of this study is to assess the safety and efficacy of the PGPI in preventing AACG following congenital cataract surgery.\n\nThis is a retrospective, nonrandomized comparative trial with historical control. The congenital cataract patients performed with cataract extraction combined with PPI (PPI group) and the patients performed with cataract extraction alone and leaving the iris intact (historical control group) were enrolled and a retrospective medical chart review was conducted. The IOP, anterior chamber depth, corneal clarity, patency of peripheral iridectomy opening, and the rate of AACG, iris posterior synechia (IPS) and visual axis opacity (VAO) were compared between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. patients less than 2 years old;\n2. patients performed with congenital cataract surgery with or without PPI;\n3. patients with routine follow-up at ZOC.\n\nExclusion Criteria:\n\n1. patients with IOP ≥21 mm Hg or with congenital glaucoma or with a family history of glaucoma;\n2. patients with keratopathy, retinopathy, ocular trauma, radiation therapy or intraocular surgery;\n3. patients associated with other congenital ocular anomalies, such as anterior segment dysgenesis, microcornea/microphthalmia, persistent fetal vasculature, lens dislocation and iridocoloboma;\n4. patients with systemic diseases, such as Down's syndrome, Lowe syndrome, Stickler syndrome, maternal rubella syndrome or trisomy 13."}, 'identificationModule': {'nctId': 'NCT03610295', 'briefTitle': 'Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'A Novel Prophylactic Peripheral Iridectomy Prevents Aphakic Angle-closure Glaucoma After Congenital Cataract Surgery', 'orgStudyIdInfo': {'id': '2018KYPJ091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPI group', 'description': 'cataract extraction surgery with prophylactic peripheral iridectomy', 'interventionNames': ['Procedure: PPI group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'historical control group', 'description': 'cataract extraction surgery', 'interventionNames': ['Procedure: cataract extraction']}], 'interventions': [{'name': 'PPI group', 'type': 'PROCEDURE', 'description': 'The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.', 'armGroupLabels': ['PPI group']}, {'name': 'cataract extraction', 'type': 'PROCEDURE', 'description': 'The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.', 'armGroupLabels': ['historical control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhongshan Ophthalmic Center, Sun Yet-san University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Yizhi Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor,director of Zhongshan Ophthalmic Center', 'investigatorFullName': 'Yizhi Liu', 'investigatorAffiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}}}}