GlaucomaNCT01726569
Post-operative Satisfaction With Glaucoma Surgery Trial
A study testing film and trained counseling and traditional counseling 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?
- film and trained counseling and traditional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Mar 2014
- 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.
About this study
Official title: A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With 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 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.
- Conditions
- Glaucoma
- Being tested
- film and trained counseling, traditional counseling
- Keywords
- glaucoma, educational intervention, post-operative satisfaction, knowledges
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
film and trained counselingBehavioural
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.
traditional counselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| film and trained counseling | Experimental | 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 Receives: Behavioral: film and trained counseling; Other: traditional counseling |
| traditional counseling | Other | Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse. Receives: Other: traditional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative satisfaction rate in both group
the rate of satisfaction
Measured: after surgery up to 6 weeks
Secondary outcomes (4)
knowledge about glaucoma
the knowledge about glaucoma scores
Measured: before surgery and after surgey 1 week and 6 weeks
willingness to recommend surgery
The rate of willingness to recommend surgery
Measured: after surgery 1 week and 6 weeks
personality in both groups
use Eysenck Personality Questionnaire-Revised Short Scale for Chinese(EPQ_RSC) access glaucoma patients personality
Measured: Baseline (before surgery)
intraocular pressure and visual acuity in both groups
intraocular pressure and visual acuity in both groups
Measured: before surgery and after surgery 1week and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (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
- Supportive care
- 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, Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726569
- Sponsor's protocol ID
- ZOC-CREST1
- Status last verified
- Dec 2021
- First submitted
- 10 Nov 2012
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China
- ClinicalTrials.gov ID
- NCT01726569
- Acronym / sponsor ID
- ZOC-CREST1
- Conditions
- Glaucoma
- Keywords
- glaucoma, educational intervention, post-operative satisfaction, knowledges
- 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
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 15 Nov 2012 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| film and trained counseling | Experimental | Behavioral: film and trained counseling, Other: traditional counselingSubjects 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 |
| traditional counseling | Other | Other: traditional counselingSubjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse. |
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 |
|---|---|---|
| film and trained counselingSubjects 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. | Behavioural | film and trained counseling |
| traditional counselingSubjects 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. | Other | film and trained counseling, traditional counseling |
Primary outcome
postoperative satisfaction rate in both group
Time frame: after surgery up to 6 weeks
the rate of satisfaction
4 secondary outcomes
knowledge about glaucoma
Time frame: before surgery and after surgey 1 week and 6 weeks
willingness to recommend surgery
Time frame: after surgery 1 week and 6 weeks
personality in both groups
Time frame: Baseline (before surgery)
intraocular pressure and visual acuity in both groups
Time frame: before surgery and after surgery 1week and 6 weeks
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 21 Dec 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
Zhongshan Ophthalmic Center,Sun Yat-sen University;ORBIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing film and trained counseling and traditional counseling 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 21 Dec 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?
postoperative satisfaction rate in both group (time frame: after surgery up to 6 weeks). 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 21 Dec 2021.