Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-23 @ 8:08 PM
Study NCT ID:
NCT03907358
Status:
UNKNOWN
Last Update Posted:
2019-04-09
First Post:
2019-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pathogenesis of Human Senile Cataract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D054140', 'term': 'Refractive Surgical Procedures'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D059708', 'term': 'Ultrasonic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-06', 'studyFirstSubmitDate': '2019-04-04', 'studyFirstSubmitQcDate': '2019-04-06', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of miRNA in micro-scale human aqueous humor', 'timeFrame': '12 month', 'description': 'method development for miRNA detection in aqueous humor'}, {'measure': 'Favored amplification recovery via protection-chromatin immunoprecipitation-Seq of human eye tissue samples', 'timeFrame': '24 month', 'description': 'low-cell-number epigenome profiling for study of cataract'}, {'measure': 'Study of cataract by genomics, transcriptomics, and proteomics approaches', 'timeFrame': '36 month', 'description': 'detect histone H3 lysine 4 trimethylation (H3K4me3) of aqueous humor of cataract patients by genomics, transcriptomics, and proteomics methods'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'To study the pathological mechanism of cataract by genomics, transcriptomics, and proteomics.', 'detailedDescription': 'Tissue samples and aqueous humor samples will be collected from each individual patients by cataract surgery. After sample treatment, different techniques will be applied for analysis. And bioinformatics approach is applied for data treatment and analysis.The data of genomics, transcriptomics, and proteomics will be analyzed for study of pathological mechanism of cataract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '94 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the explicit diagnosis of cataract are willing to undergo cataract surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the explicit diagnosis of cataract (including senile cataract, congenital cataract, complicated cataract, metabolic cataract, traumatic cataract, etc.) in the operated eye are willing to undergo cataract surgery.\n\nExclusion Criteria:\n\n* Patients whose cataracts need not be operated\n* Patients with any contraindications to cataract surgery\n* Patients are unwilling to undergo cataract surgery'}, 'identificationModule': {'nctId': 'NCT03907358', 'briefTitle': 'The Pathogenesis of Human Senile Cataract', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'The Pathogenesis of Age-related Cataract', 'orgStudyIdInfo': {'id': 'Shanghai1st-cataract-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cataract in old age', 'interventionNames': ['Procedure: phacoemulsification']}, {'label': 'cataract in young age', 'interventionNames': ['Procedure: phacoemulsification']}], 'interventions': [{'name': 'phacoemulsification', 'type': 'PROCEDURE', 'armGroupLabels': ['cataract in old age', 'cataract in young age']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haidong Zou, Dr.', 'role': 'CONTACT', 'email': 'zouhaidong@hotmail.com', 'phone': '86-21-63240090', 'phoneExt': '6833'}], 'facility': 'Department of Ophthalmology, Shanghai General Hospital, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Haidong Zou', 'role': 'CONTACT', 'email': 'zouhaidong@hotmail.com', 'phone': '86-21-63240090', 'phoneExt': '6833'}, {'name': 'Bijun Zhu', 'role': 'CONTACT', 'email': 'judyzhu52@163.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Haidong Zou', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}