A Randomized Controlled Trial on the Impact of an Educational Video on Satisfaction After Glaucoma Surgery in Urban and Rural China
Phase: NA
Conditions: Glaucoma
Sponsor: Sun Yat-sen University

 
 
A Randomized Controlled Trial on the Impact of an Educational 
Video on Satisfaction After Glaucoma Surgery in Urban and Rural 
China  
 
STUDY IDENTIFER:  
LAST UPDATED: March 18, 2019 
 
STUDY PROTOCOL 
 
Principal Investigator (Wenzhou) – Prof Liang Yuanbo MD PHD1 
Principal Investigator (Orbis, QUB) – Prof Nathan Congdon MD MPH2, 3, 4 
 
Co-Investigators 
Alice Liu1  
Lin Hao1  
 
1 1The Eye Hospital, School of Ophthalmology and Optometry, Wenzhou Medical University, 
Wenzhou, Zhejiang, China 
2 Queen’s University, Belfast, UK 
3 Orbis International, NY, USA 
4 Zhongshan Ophthalmic Centre, Guangzhou, China 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Executive Summary 
 
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 of a multi-media educational intervention on post-operative 
satisfaction. This educational consultation is designed to give patients a realistic expectation of 
their post-operative course: glaucoma surgery is being performed NOT to improve vision, but to 
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 from two centers – one urban hospital at Wenzhou Eye Hospital and  
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 
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. 
 
 
 
 
 
 
 
 
 
 
 

 
 
Background Literature Review  
 
Glaucoma is the leading cause of irreversible blindness worldwide, with Asia accounting for 60% 
of the estimated number of people with glaucoma (64.3 million) in 2013.1 In China alone, there 
are nearly 10 million cases, suggesting a strong need for public health strategies to alleviate this 
important health issue.2,3  
 
Current glaucoma treatment strategies involve reducing or lowering a patient’s elevated 
intraocular pressure, with the most effective approaches employing either eye drops, laser 
therapy, or surgery. Additionally, glaucoma treatment requires long-term follow-up care, 
making patient compliance central to a successful regimen.4 However, the treatment of 
glaucoma in low-resource settings presents significant issues, as the disease is typically 
asymptomatic until substantial, irreversible vision loss has already occurred.5 Poor adherence 
to follow-up6,7 and misconceptions in rural China about glaucoma as a symptomatic disease 
makes topical medicine an unlikely sustainable option for treatment.5 
 
Yet, surgery as the primary treatment modality for glaucoma in rural China come with its own 
set of challenges. It has been well documented that vision after glaucoma surgery declines 
initially, with the majority of cases resolving over 1-6 weeks. 8 Concerns about dis-satisfaction 
with vision may lead to negative attitudes towards surgery in the community, and affect uptake 
of not only glaucoma surgery, but also other eye operations, particularly cataract, the leading 
cause of global blindness, and which can only be treated surgically. Rural community 
acceptance of surgery is of particular importance because sources of knowledge about 
glaucoma primarily come from friends, relatives and the news, but not physicians.5  
 
Traditionally, the preoperative procedure for glaucoma surgery entails a comprehensive 
discussion between the physician and patient about the role of surgery, but it is unclear how 
effective these sessions are at disseminating information.9,10 Of primary concern is the extent to 
which patients comprehend the purpose of glaucoma surgery as a mechanism to prevent future 
vision loss, rather than recover lost vision. This problem is particularly acute in rural Chinese 
settings, where patient loads are heavy, and time for detailed discussions may be limited. The 
situation is further complicated by limited knowledge among caregivers in many cases, and 
well-documented lack of trust between physicians and patients in rural China. 11 
 
Educational interventions employing videos to assist in the preoperative informed consent 
process have shown visual aids to be a promising tool for increasing patient comprehension and 
satisfaction.12,13,14 Even more essential is the repetition of information in improving patient 
understanding.12  
 
For this study, we will evaluate the effectiveness of repeated showings of an educational video 
has in raising patient satisfaction with glaucoma surgery.  

 
 
Objectives 
 
 
Overall Objective: This study will assess whether an educational video is effective in increasing 
patient satisfaction with glaucoma surgery.  
 
1. Investigate the impact of educational interventions on glaucoma patients' surgical 
satisfaction. 
2. Investigate the post-operative satisfaction of rural glaucoma patients in county hospitals  
3. Investigate the difference in postoperative satisfaction between urban and rural 
glaucoma patients in urban hospitals 
4. Investigate other factors that influence postoperative glaucoma satisfaction. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
Methodology  
 
Study Design: Randomized controlled trial of an educational intervention. 
 
Study Population: Patients scheduled to undergo glaucoma surgery at either the Wenzhou Eye 
Hospital or at four rural county-level hospitals in Guangdong province.  
 
Since there may be existing differences in baseline glaucoma surgery satisfaction levels due to 
patients’ place of residence and choice of hospital, we will divide our study population into the 
following three groups:  
• Group 1: Urban patients seeking glaucoma surgical treatment at an urban hospital.  
• Group 2: Rural patients seeking glaucoma surgical treatment at an urban hospital.  
• Group 3: Rural patients seeking glaucoma surgical treatment at a rural or county-level 
hospital.  
 
Recruited patients from Wenzhou Eye Hospital will be separated into Groups 1 and 2 based off 
place of residence. Recruited patients from the Guangdong CREST county-level hospitals will be 
enrolled into Group 3.  Each of these groups will be randomized separately (stratified 
randomisation) to ensure a balance across study groups with regard to this characteristic. 
 
Sample Size Calculations: 264 total patients   
 
Patient Enrolment Criteria:  
• Glaucoma patients ≥ 18 years of age undergoing trabeculotomy or iridotomy   
 
Patient Exclusion Criteria:  
• VA < 20/400 (0.05)  
• Patients who had previously undergone trabeculotomy 
• Severe mental disabilities preventing participants from completing a self-administered 
questionnaire  
 
Intervention: Subjects will be asked to watch a 5-10 min education film two times (pre-op one 
day and post-op one day).   
 
Control: Standard patient procedure that includes a pre-operative discussion with an 
ophthalmologist about glaucoma surgery, during which the surgeon gains the patient’s informed 
consent. Subjects will not be asked to watch education film. 
 
Outcomes 
 
Main outcome: The mean satisfaction outcome over two follow-up visits (1 day and 1 week).  

 
 
 
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. (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) 
 
While our satisfaction questionnaire has not been previously validated, it contains several items 
from the Glaust questionnaire, a validated questionnaire measuring patient satisfaction with 
glaucoma treatment. (Ruiz, M. A., Pardo, A., Martinez de la Casa, J. M., Polo, V., Esquiro, J., & 
Soto, J. (2010). Development of a specific questionnaire measuring patient satisfaction with 
glaucoma treatment: Glausat. Ophthalmic epidemiology, 17(3), 131-143.) 
 
Secondary outcomes:  
 
2. The rate of willingness to recommend surgery to a friend or relative with glaucoma 
Measurement method: Satisfaction questionnaire 
 
3. Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for 
Chinese (EPQ-RSC) to assess glaucoma patients’ personality. This test measures four aspects of 
an individual’s personality traits: extraversion, neuroticism, presence of psychoticism 
(aggressiveness or hostility), and lie (tendency to conform).  
 
4. Knowledge scores about glaucoma.  
 
5. Intraocular pressure in both groups. Unit of Intraocular pressure is mmHg. 
 
6. 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) 
 
Informed Consent 
 
Informed consent to participate in an educational intervention will be obtained.  A standard 
consent form will be employed and will indicate that, as part of an educational randomized 
control trial, some of the participants will receive free consultations with a health professional. 
If they are unable to read it, the form will be read to them in Chinese. Afterwards, they will be 
invited to sign.   
 
Participant Withdrawal 
Patients in either the intervention or control group are free to leave the study at any time. Data 
collected up to the point of withdrawal of consent will be anonymized, securely stored, and be 
included in data analysis.  

 
 
 
Randomisation 
Pre-randomization baseline assessment 
Following consent, baseline patient satisfaction levels with previous glaucoma treatment and 
medical care will be evaluated. Patients will be categorized as “urban” or “rural” based off their 
place of residence and separated into their designated groups based off place of residence and 
hospital.  
 
Randomization: Patients will be randomized based off clinic week. For example, all patients 
having surgery one week will watch the video and be placed in the intervention group. The 
following week, all patients will be placed in the control week.   
 
Baseline data: 
• Patient 
o Age/Sex 
o Profession 
o Martial Status  
o Long-term Residence  
o Distance from home to hospital  
o Time from home to hospital  
o Current glaucoma treatment  
o Baseline uncorrected and best-corrected visual acuity in operative eye  
o Intraocular pressure in operative eye  
 
The Intervention 
 
Subjects will be asked to watch a 5-10 min education film. These sessions will occur during their 
pre-operative and post-operative 1 day visit.  
 
The film follows the journey of an elderly patient scheduled to undergo glaucoma surgery, 
beginning with a face-to-face Q&A health session with an eye doctor. After surgery, the patient 
talks about his post-operative eyesight and discusses the benefits of early diagnosis and 
glaucoma surgery for treatment with his community.  
 
 
 
 
 
 
 
Participant Recruitment Timeline 
 

 
 
An administrator will schedule a time for patients to come in for surgery. When patients come 
for their pre-surgery visitation, they will be approached for study recruitment. After signing the 
informed consent form denoting their voluntary participation into the study, they will fill out 
three questionnaires: 1) Personality (EPQ-RSC) 2) Knowledge of glaucoma treatment.  
Based off their identity as an “urban” or “rural” patient, they will be separated accordingly into 
the different groups. Randomization will be determined by clinic week.  
 
The timetable displays what questionnaires will be filled out at each visitation for the control 
and intervention group.  
 
 
Control Group  
Intervention Group  
Pre-Surgery Visitation 
1. Informed consent  
2. Personality (EPQ-RSC) 
3. Knowledge of glaucoma treatment 
4. Baseline Satisfaction questionnaire  
5. Informed consent  
6. Personality (EPQ-RSC) 
7. Knowledge of glaucoma treatment 
8. Baseline satisfaction questionnaire  
9. Video  
Surgery  
 
Post-surgery Day 1 
1.  Satisfaction questionnaire 
1. Satisfaction questionnaire  
2. Video  
Post-surgery Week 1 
1. Satisfaction questionnaire  
2. Knowledge of glaucoma treatment  
1. Satisfaction questionnaire  
2. Knowledge of glaucoma treatment 
 
Analyses 
 
Statistical Analysis 
 
• 
Mean patient satisfaction grade for cumulative scores from 2 satisfaction 
questionnaires, comparing intervention and control groups, with and without 
adjustment for baseline patient factors.   
 
Prevention of Bias 
 
Potential Harms and Benefits of the Study 
 
Potential Harms 
There are no clinical harms from the study protocol itself, as the intervention group is solely 
receiving additional health counseling sessions.    
 
Potential Benefits 
The patients in the intervention group will receive additional counseling with a health 
professional, which may deepen their understanding of glaucoma surgery 

 
 
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