Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-05 @ 2:07 PM
Study NCT ID:
NCT03908359
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2019-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
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': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2019-04-06', 'studyFirstSubmitQcDate': '2019-04-08', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': 'up to five years of age', 'description': "Determined with the Teller's acuity card, the Lea symbol visual acuity chart or the ETDRS chart according the patient's age."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital Cataract', 'minimal invasive surgery', 'secondary intraocular lens implantation'], 'conditions': ['Congenital Cataract']}, 'descriptionModule': {'briefSummary': 'Previously, the investigators have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.', 'detailedDescription': 'Patients with congenital cataract that requires surgical intervention are enrolled.\n\nThen the participants are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 1 month and 24 months\n* Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag\n* Informed consent signed by a parent or legal guardian\n\nExclusion Criteria:\n\n* confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract\n* Intraocular pressure \\>21 mmHg\n* Preterm birth (\\<28 weeks)\n* Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)\n* History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family\n* History of ocular trauma\n* Microcornea\n* Persistent hyperplastic primary vitreous\n* Rubella\n* Lowe syndrome'}, 'identificationModule': {'nctId': 'NCT03908359', 'briefTitle': 'Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts', 'orgStudyIdInfo': {'id': 'CCPMOH2018-China11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'traditional cataract surgery', 'description': 'Central anterior continuous capsulorhexis opening (5-6 mm)+ lens irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit)', 'interventionNames': ['Procedure: traditional cataract surgery']}, {'type': 'EXPERIMENTAL', 'label': 'minimal invasive lens surgery', 'description': 'Peripheral capsulorhexis opening (1.0-1.5 mm)+lens irrigation/aspiration', 'interventionNames': ['Procedure: minimal invasive lens surgery']}], 'interventions': [{'name': 'traditional cataract surgery', 'type': 'PROCEDURE', 'description': 'ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy', 'armGroupLabels': ['traditional cataract surgery']}, {'name': 'minimal invasive lens surgery', 'type': 'PROCEDURE', 'description': 'We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities.', 'armGroupLabels': ['minimal invasive lens surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haotian Lin, Phd', 'role': 'CONTACT', 'email': 'gddlht@gmail.com', 'phone': '+86-20-87330475'}, {'name': 'Haotian Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yizhi Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center,Sun Yat-sen U', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jing Li, M.D', 'role': 'CONTACT', 'email': 'Reviewborad_SYsU@163.com', 'phone': '+86-20-87330341'}], 'overallOfficials': [{'name': 'Yizhi Liu, M.D,Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Haotian Lin', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}