GlaucomaNCT02629237
Satisfaction After Glaucoma Surgery in Rural China
A study testing Multifaceted education in people with Glaucoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients. 2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients. 3. Investigate the effect factors of postoperative satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Multifaceted education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2022to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
Who cannot join
- patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Trial locations and contacts
1 site in 1 country.
China1 site
Blindness Preventment and Treatment Department
Guangzhou, Guangdong, 510060
About this study
Official title: Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China
- 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.
Read the detailed description
Glaucoma is the leading cause of irreversible blindness in China, as elsewhere in the world. In Chinese rural settings, where topical glaucoma medication is unlikely to be a practical and sustainable option, surgery is the primary treatment modality for glaucoma. However, it is known that vision is quite likely to decline in the short to medium term after glaucoma surgery, and there are concerns that dis-satisfaction resulting from such vision changes might lead to negative social marketing, affecting uptake not only of glaucoma surgical care but other eye operations (principally cataract) as well. We propose to test the impact on post-operative satisfaction of a multi-media educational intervention designed to give patients a realistic expectation of their post operative course: glaucoma surgery is being performed NOT to improve vision, but do protect it from future harm, and vision may in fact decline for several weeks post operatively. A randomized controlled design will be used, and subjects undergoing glaucoma surgery will be enrolled at 4 rural county hospitals in rural Guangdong province, and randomized to receive the intervention or usual care. The principal outcome will be subjective satisfaction on a previously-tested questionnaire instrument, administered pre-operatively and post-operatively on two occasions in the first month following surgery. Patients not returning post-operatively to the surgical facility will be contacted by telephone for administration of the questionnaire. Other facility- and patient-related clinical and personal factors expected to influence satisfaction will also be recorded, and adjusted for in all analyses.
- Conditions
- Glaucoma
- Being tested
- Multifaceted education
- Keywords
- glaucoma surgery, educational intervention, satisfaction, rural
- Medical subject headings
- Glaucoma, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted educationOther
Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Multifaceted education group | Experimental | Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery. Receives: Other: Multifaceted education |
| control group | No intervention | Subjects will not be asked to watch education film and not participate in counseling session before and after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean satisfaction score over three follow-up visits
The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was assessed as a cumulative score.
Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)
Measured: 1 week, 2 week and 4 week after surgery.
Secondary outcomes (5)
The rate of willingness to recommend surgery to a friend or relative with glaucoma
The measurement method:questionnaire
Measured: 1 week, 2 week and 4 week after surgery.
Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
Measured: before surgery
Knowledge scores about glaucoma
Measured: before surgery and 1 week, 2 week and 4 week after surgery
Intraocular pressure in both groups
Unit of Intraocular pressure is mmHg.
Measured: before surgery and 1 week, 2 week and 4 week after surgery
visual acuity in both groups
Visual acuity testing use Snellen-based letter charts,such as a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is 0.3)
Measured: before surgery and 1 week, 2 week and 4 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2015 (estimated)
- Study startMar 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: study sites were reconsidered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan Congdon, MD,MPH, Principal investigator, The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629237
- Sponsor's protocol ID
- ZOC-CREST-Satisfaction
- Status last verified
- Sep 2021
- First submitted
- 9 Oct 2015
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China
- ClinicalTrials.gov ID
- NCT02629237
- Acronym / sponsor ID
- ZOC-CREST-Satisfaction
- Conditions
- Glaucoma
- Keywords
- glaucoma surgery, educational intervention, satisfaction, rural
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study sites were reconsidered.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 14 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 of irreversible blindness in China, as elsewhere in the world. In Chinese rural settings, where topical glaucoma medication is unlikely to be a practical and sustainable option, surgery is the primary treatment modality for glaucoma. However, it is known that vision is quite likely to decline in the short to medium term after glaucoma surgery, and there are concerns that dis-satisfaction resulting from such vision changes might lead to negative social marketing, affecting uptake not only of glaucoma surgical care but other eye operations (principally cataract) as well. We propose to test the impact on post-operative satisfaction of a multi-media educational intervention designed to give patients a realistic expectation of their post operative course: glaucoma surgery is being performed NOT to improve vision, but do protect it from future harm, and vision may in fact decline for several weeks post operatively. A randomized controlled design will be used, and subjects undergoing glaucoma surgery will be enrolled at 4 rural county hospitals in rural Guangdong province, and randomized to receive the intervention or usual care. The principal outcome will be subjective satisfaction on a previously-tested questionnaire instrument, administered pre-operatively and post-operatively on two occasions in the first month following surgery. Patients not returning post-operatively to the surgical facility will be contacted by telephone for administration of the questionnaire. Other facility- and patient-related clinical and personal factors expected to influence satisfaction will also be recorded, and adjusted for in all analyses.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifaceted education group | Experimental | Other: Multifaceted educationSubjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery. |
| control group | No intervention | –Subjects will not be asked to watch education film and not participate in counseling session before and after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy
Key exclusion criteria (1 listed)
- patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multifaceted educationSubjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery. | Other | Multifaceted education group |
Primary outcome
The mean satisfaction score over three follow-up visits
Time frame: 1 week, 2 week and 4 week after surgery.
The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was assessed as a cumulative score. Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)
5 secondary outcomes
The rate of willingness to recommend surgery to a friend or relative with glaucoma
Time frame: 1 week, 2 week and 4 week after surgery.
Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
Time frame: before surgery
Knowledge scores about glaucoma
Time frame: before surgery and 1 week, 2 week and 4 week after surgery
Intraocular pressure in both groups
Time frame: before surgery and 1 week, 2 week and 4 week after surgery
visual acuity in both groups
Time frame: before surgery and 1 week, 2 week and 4 week after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Congdon, MD,MPH principal investigator
The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted education in people with Glaucoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean satisfaction score over three follow-up visits (time frame: 1 week, 2 week and 4 week after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.