Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 8:53 AM
Study NCT ID:
NCT01726569
Status:
WITHDRAWN
Last Update Posted:
2021-12-21
First Post:
2012-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Satisfaction With Glaucoma Surgery Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009040', 'term': 'Motion Pictures'}], 'ancestors': [{'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study sites were reconsidered.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-05', 'studyFirstSubmitDate': '2012-11-10', 'studyFirstSubmitQcDate': '2012-11-14', 'lastUpdatePostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative satisfaction rate in both group', 'timeFrame': 'after surgery up to 6 weeks', 'description': 'the rate of satisfaction'}], 'secondaryOutcomes': [{'measure': 'knowledge about glaucoma', 'timeFrame': 'before surgery and after surgey 1 week and 6 weeks', 'description': 'the knowledge about glaucoma scores'}, {'measure': 'willingness to recommend surgery', 'timeFrame': 'after surgery 1 week and 6 weeks', 'description': 'The rate of willingness to recommend surgery'}, {'measure': 'personality in both groups', 'timeFrame': 'Baseline (before surgery)', 'description': 'use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ\\_RSC) access glaucoma patients personality'}, {'measure': 'intraocular pressure and visual acuity in both groups', 'timeFrame': 'before surgery and after surgery 1week and 6 weeks', 'description': 'intraocular pressure and visual acuity in both groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['glaucoma', 'educational intervention', 'post-operative satisfaction', 'knowledges'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': '1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.\n2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.\n3. Investigate the effect factors of postoperative satisfaction.', 'detailedDescription': 'Glaucoma is the leading cause irreversible blindness worldwide, but only less than 10% glaucoma patients were diagnosed in the country of Asia areas. In the country of China, patients who are low educational level and less known acknowledgement and information have less known glaucoma. In the help of the government and some international non-governmental organizations(NGOs), a lot of people in the country know the cataract, and the operability of cataract is increase. Because vision loss usually development after operation for glaucoma. If patients did not understand this, they may be not only do not accept operation, but also affect operability of cataract. We hope the educational intervention for glaucoma can increase the degree of satisfaction in glaucoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy\n\nExclusion Criteria:\n\n* patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia'}, 'identificationModule': {'nctId': 'NCT01726569', 'briefTitle': 'Post-operative Satisfaction With Glaucoma Surgery Trial', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China', 'orgStudyIdInfo': {'id': 'ZOC-CREST1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'film and trained counseling', 'description': 'Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session and follow up counseling after operation 1 week and 6 weeks', 'interventionNames': ['Behavioral: film and trained counseling', 'Other: traditional counseling']}, {'type': 'OTHER', 'label': 'traditional counseling', 'description': "Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.", 'interventionNames': ['Other: traditional counseling']}], 'interventions': [{'name': 'film and trained counseling', 'type': 'BEHAVIORAL', 'description': 'Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session.', 'armGroupLabels': ['film and trained counseling']}, {'name': 'traditional counseling', 'type': 'OTHER', 'description': "Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.", 'armGroupLabels': ['film and trained counseling', 'traditional counseling']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Nathan Congdon, MD,MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guangdong Educational Intervention for Rural Glaucoma surgical patient', 'investigatorFullName': 'Congdon Nathan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}