Back to resultsPost-operative Satisfaction With Glaucoma Surgery Trial
Primary Purpose
Glaucoma
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
film and trained counseling
traditional counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Glaucoma focused on measuring glaucoma, educational intervention, post-operative satisfaction, knowledges
Eligibility Criteria
Inclusion Criteria:
- age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
Exclusion Criteria:
- patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Sites / Locations
- Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
film and trained counseling
traditional counseling
Arm 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
Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.
Outcomes
Primary Outcome Measures
postoperative satisfaction rate in both group
the rate of satisfaction
Secondary Outcome Measures
knowledge about glaucoma
the knowledge about glaucoma scores
willingness to recommend surgery
The rate of willingness to recommend surgery
personality in both groups
use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality
intraocular pressure and visual acuity in both groups
intraocular pressure and visual acuity in both groups
Full Information
NCT ID
NCT01726569
First Posted
November 10, 2012
Last Updated
December 5, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT01726569
Brief Title
Post-operative Satisfaction With Glaucoma Surgery Trial
Official Title
A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
study sites were reconsidered.
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
March 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.
Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.
Investigate the effect factors of postoperative satisfaction.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, educational intervention, post-operative satisfaction, knowledges
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
film and trained counseling
Arm Type
Experimental
Arm 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
Arm Title
traditional counseling
Arm Type
Other
Arm Description
Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.
Intervention Type
Behavioral
Intervention Name(s)
film and trained counseling
Intervention 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.
Intervention Type
Other
Intervention Name(s)
traditional counseling
Intervention 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.
Primary Outcome Measure Information:
Title
postoperative satisfaction rate in both group
Description
the rate of satisfaction
Time Frame
after surgery up to 6 weeks
Secondary Outcome Measure Information:
Title
knowledge about glaucoma
Description
the knowledge about glaucoma scores
Time Frame
before surgery and after surgey 1 week and 6 weeks
Title
willingness to recommend surgery
Description
The rate of willingness to recommend surgery
Time Frame
after surgery 1 week and 6 weeks
Title
personality in both groups
Description
use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality
Time Frame
Baseline (before surgery)
Title
intraocular pressure and visual acuity in both groups
Description
intraocular pressure and visual acuity in both groups
Time Frame
before surgery and after surgery 1week and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
Exclusion Criteria:
patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD,MPH
Organizational Affiliation
Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Post-operative Satisfaction With Glaucoma Surgery Trial
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