Condition category
Eye Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Previous research has revealed that rural China is currently experiencing a vision (eye) care crisis. According to estimates, 215 million individuals in rural China aged 5 years and above suffer from poor vision. Furthermore, it has been found that virtually no village clinics offer optometric services and only one in five township health centers do. However, due to lack of research and objective measures for quality of care, it is difficult to work out how to best meet the vision care needs of rural China.The purpose of this study is two-fold: first, to assess quality of optical care services across public and private optical facilities in China and, second, to identify existing barriers to optical care. In order to assess the quality of optical care services, this study will include what is referred to as a standardized patient module, in which trained student actors will pose as regular patients seeking optical care at local optical facilities. Due to the nature of the study, the staff will not be informed of the standardized patient visits.

Who can participate?
Student actors posing as patients. All are Shaanxi Normal University graduate students between the ages of 22 and 30 years old.

What does the study involve?
Each student actor is trained to pretend to have blurry vision and wrong prescription glasses. Each also present themselves as a poor individual at some times and a wealthy individual at others (e.g., by altering clothes, accent, indicating budget, etc.). All actors present themselves at two public vision centres and four private vision shops and say that they are seeking a second opinion. All patient student actors record information related to any optical vision examinations they have done and their and results, their treatment by the optical staff, facility equipment, and cost of services offered.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
A number of public and private optic clinics in China.

When is the study starting and how long is it expected to run for?
September 2016 to October 2016

Who is funding the study?
Stanford University (USA)

Who is the main contact?
Mr Matthew Boswell

Trial website

Contact information



Primary contact

Mr Matthew Boswell


Contact details

Rural Education Action Program
Encina Hall
616 Serra Street
United States of America

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Using standardized patients to measure quality of care in public and private optical health facilities across China


Study hypothesis

The primary aim of this study is to identify the quality of optic care across public and private optical facilities in China. The standardized patients will record information on diagnosis quality, optical staff treatment, facility equipment, and cost of services. Additionally, the acquired information will identify potential barriers to receiving vision care.

Ethics approval

Stanford University IRB, ref: 25904

Study design

Observational cross sectional study

Primary study design


Secondary study design

Cross sectional study

Trial setting


Trial type


Patient information sheet

No participant information sheet available


Quality of vision care in China


In this study, 60 trained student actors will serve as standardized patients at private optical clinics and public vision centers in China. Each student actor will be trained to feign blurry vision and wrong prescription glasses, each student actor will indicate a wealthy appearance and a poor appearance (e.g., by altering clothes, accent, indicating budget, etc.), each will be trained to say they are seeking a second opinion. All standardized patient student actors will visit two public vision centers and four private vision shops within or near their hometown.

Due to the nature of the study, the optical facility staff will not be informed of the standardized patient visits. As the standardized patient actors will be visiting between 300 and 360 private and public optical centers, it is not feasible and would significantly influence the research findings if each optical facility were informed of the upcoming standardized patient visit.

This study is cross-sectional (researchers will not follow up with the optic care facilities). As for timing, the preparation for the standardized patients and the actual testing will take 1-2 months. Visits by the standardized patients will take around 40 days. Data cleaning and analysis will take approximately 4 months.

Intervention type



Drug names

Primary outcome measures

1. Quality of delivered optical care as measured by:
1.1 Correct refraction procedure observed by standardized patient during visit
1.2. Correct prescription attained during visit
1.3. Whether eye glasses match prescription at the time eye glasses are obtained

Secondary outcome measures

1. Cost of exam paid by standardized patient during visit
2. Cost of eyeglasses paid by standardized patient during visit

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Optical facility staff:
1. Working in an optical facility
3. Split between rural and urban parts of China
4. Adults

Student actors:
5. Graduate students at Shaanxi Normal University
6. Between 22 and 30 years old

Participant type


Age group




Target number of participants


Participant exclusion criteria

Participants not fulfilling the inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Number of public and private optic clinics in China

Sponsor information


Rural Education Action Program at Stanford University

Sponsor details

Encina Hall
616 Serra Street
CA 94305-6055
United States of America

Sponsor type




Funder type


Funder name

Stanford University

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes