Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 11:46 PM
Study NCT ID:
NCT03020056
Status:
COMPLETED
Last Update Posted:
2021-03-30
First Post:
2016-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Cataract Surgery to Socioeconomic Status in Rural Area
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002387', 'term': 'Cataract Extraction'}, {'id': 'D018918', 'term': 'Phacoemulsification'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-29', 'studyFirstSubmitDate': '2016-11-26', 'studyFirstSubmitQcDate': '2017-01-12', 'lastUpdatePostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'annual personal income by work in Chinese Yuan', 'timeFrame': '1 year', 'description': 'The annual personal income comprises of the direct and the indirect income by work. The indirect income is derived from unpaid work and calculated as follows: unpaid work time × local income per hour.'}], 'secondaryOutcomes': [{'measure': 'Health-related quality of life score', 'timeFrame': '1 year', 'description': 'Health-related QoL score will be measured by EuroQol 5 dimensions with 5 levels (EQ-5D-5L) and self-rated health (SRH). For each dimension, participants are asked to mark between 1: "no problems" to 5: "unable to/extreme problems". Self-rated health using a vertical Visual Analogue Scale (VAS), with scores ranging from 0 (representing worst imaginable health state) to 100 (best imaginable health state).\n\n1. mobility\n2. self-care\n3. usual activities\n4. pain/discomfort\n5. anxiety/depression f: self-rated health'}, {'measure': 'Vision related quality of life score', 'timeFrame': '1 year', 'description': 'Vision related QoL score will be measured by Catquest-9S, which is a short form of Catquest questionnaire. The Catquest-9SF questionnaire comprises 7 questions for performing daily-life activities and 2 global questions about difficulties in general and satisfaction with vision (1= very great difficulty; 2= great difficulty; 3= some difficulty; 4= no difficulty).\n\n1. reading text in the newspaper\n2. recognizing faces of people you meet\n3. seeing prices of goods when shopping\n4. seeing to walk on uneven ground\n5. seeing to do needlework and handicraft\n6. reading text on television\n7. seeing to carry out a preferred hobby\n8. difficulty in daily life\n9. satisfaction on present vision'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cataract surgery', 'socioeconomic status', 'quality of life', 'rural area', 'China', 'randomized controlled trial'], 'conditions': ['Cataract Surgery']}, 'referencesModule': {'references': [{'pmid': '37523426', 'type': 'DERIVED', 'citation': 'Tan X, Han X, Zheng Y, Jin L, Qiu X, Zhu Y, Chen C, Zhang J, Dickey H, Wang D, Huang S, Liu B, Liang X, Zeng Y, Lin H, He M, Luo L, Huang W, Congdon N, Liu Y. Impact of Cataract Surgery on Income in Rural Southern China: The SUCCESS Randomized Controlled Trial. Asia Pac J Ophthalmol (Phila). 2023 Jul-Aug 01;12(4):355-363. doi: 10.1097/APO.0000000000000624. Epub 2023 Jul 21.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to investigate the effect of cataract surgery on the socioeconomic status of cataract patients in rural area of Southern China.', 'detailedDescription': "Cataract is the leading cause of visual impairment worldwide and surgery is the only effective treatment. Previous studies show that visual impairment impacts the patient's socioeconomic status(SES). However, how cataract surgery affects the SES of cataract patients in rural area of China has not been determined before.\n\nIn the investigators study, cataract patients in rural area of Southern China will be enrolled and randomly divided into two groups. Cataract surgery will be performed in 4 weeks in intervention group, while performed at 1 year later in control group. The annual personal income by work, annual household income, hours in paid and unpaid work in the previous month, real estate ownership, household expenditures and quality of life will be investigated before and 1 year after surgery. Then, the difference in SES and quality of life change between two groups at 1 year later will be assessed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age-related cataract patients aged over 50 with best corrected visual acuity (BCVA) less than 0.3 in the better eye.\n\nExclusion Criteria:\n\n* History of other eye disease that contributes to visual impairment, including keratopathy, uveitis, glaucoma, retinopathy, ocular trauma, or intraocular surgery.\n* Cases in need of expedited surgery, including shallow anterior chamber (central anterior chamber depth less than 2 mm and/or peripheral anterior chamber depth less than 1/4 corneal thickness), blindness of grade IV and V (BCVA less than 0.02 in the better eye), and intumescent or hypermature stage of cortical cataract.\n* Systemic disease dampening activity, including cardiovascular and cerebrovascular diseases, hemiplegia, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease.\n* Patients not willing to participate in the study."}, 'identificationModule': {'nctId': 'NCT03020056', 'acronym': 'ICSSES', 'briefTitle': 'Impact of Cataract Surgery to Socioeconomic Status in Rural Area', 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': 'Impact of Cataract Surgery to Socioeconomic Status in Rural Area of Southern China: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2016KYYJ007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'waiting surgery', 'description': 'Cataract surgery will be performed at 1 year after enrollment.These participants will be provided with Phacolin eye drops(Zhongshan ophthalmic center, China).', 'interventionNames': ['Drug: Phacolin eye drops']}, {'type': 'EXPERIMENTAL', 'label': 'expedited surgery', 'description': 'Cataract surgery will be performed within 4 weeks.', 'interventionNames': ['Procedure: cataract surgery']}], 'interventions': [{'name': 'Phacolin eye drops', 'type': 'DRUG', 'otherNames': ['antioxidant eye drops'], 'description': 'After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.', 'armGroupLabels': ['waiting surgery']}, {'name': 'cataract surgery', 'type': 'PROCEDURE', 'otherNames': ['phacoemulsification or MSICS'], 'description': 'After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.', 'armGroupLabels': ['expedited surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '516300', 'city': 'Huidong', 'state': 'Guangdong', 'country': 'China', 'facility': "Huidong people's hospital", 'geoPoint': {'lat': 21.50971, 'lon': 110.48891}}], 'overallOfficials': [{'name': 'Yizhi Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, {'name': 'Yingfeng Zheng, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}