China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study
Phase: NA
Conditions: Cataract
Sponsor: Sun Yat-sen University

 
A Randomized Controlled Trial of Low-Cost Model Eyes for Cataract 
Surgical Training of Rural Chinese Ophthalmologists:  The China 
OLIMPICS (Ophthalmic Learning & Improvement Initiative in 
Cataract Surgery) Trial 
 
 
 
STUDY IDENTIFER: NCT03458442 
LAST UPDATED: OCTOBER 9, 2018  
 
STUDY PROTOCOL 
 
Principal Investigator (Beijing Tongren) – Prof Wang Ningli1    
Principal Investigator (Orbis, QUB) – Prof Nathan Congdon  MD  MPH2, 3, 4 
Principal Investigator (LSHTM) – Dr William H Dean  FRCOphth  MEd  MBChB  BSc5, 6 
 
 
Co-Investigators 
 
Christopher Magoon3 
Kang Mengtian1 
Lexi Wang3 
Mayinuer Yusufu3 
Tai Stephan3 
Dr Wang Decai4 
Dr Peter Xu3 
Dr Wen Qing2 
Dr Tang Jianjun2 
Prof Ciarin O’Neill2 
Prof Mathew Burton5 
Huang Wenyong4 
Prof Mike Clarke2 
Catherine Jan1 
 
 
 
 
1 Beijing Tongren Hospital, People’s Republic of China 
2 Queen’s University, Belfast, UK 
3 Orbis International, NY, USA 
4 Zhongshan Ophthalmic Centre, Guangzhou, China 
5 London School of Hygiene & Tropical Medicine, UK 
6 University of Cape Town, South Africa 
 
 

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This protocol describes the China-OLIMPICS* Trial, and provides information about 
procedures for selecting participants and the training involved.  
 
The protocol should not be used as a replacement curriculum for current surgical training.  
 
Questions relating to this educational-intervention study should be referred, in the first 
instance, to the primary investigators: Dr Will Dean, Profs Wang Ningli, Nathan Congdon, & 
Matthew Burton. 
 
This trial will adhere to the principles outlined in the guidelines and protocol of the 
International Conference on Harmonisation Good Clinical Practice (ICH GCP) and all applicable 
local and training programme regulations. 
 
 
 
*Ophthalmic learning & improvement initiative in cataract surgery 
 
 
 

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Glossary of Abbreviations .................................................................................................5 
Keywords .........................................................................................................................6 
General Information .........................................................................................................7 
Project Title ............................................................................................................................. 7 
Identifying numbers ................................................................................................................. 7 
Principle Investigator ............................................................................................................... 7 
Coordinating Research Institutions ........................................................................................... 7 
Collaborating Training Institutions ............................................................................................ 7 
Study Sponsor .......................................................................................................................... 8 
Study Funders .......................................................................................................................... 8 
Executive Summary ..........................................................................................................9 
Background Literature Review ........................................................................................ 10 
Cataract Surgery .................................................................................................................... 10 
Surgical Education and Simulation .......................................................................................... 11 
Rationale ........................................................................................................................ 12 
Project aims ........................................................................................................................... 12 
Objectives ...................................................................................................................... 13 
Methodology .................................................................................................................. 14 
Study Design .......................................................................................................................... 14 
Study Population ................................................................................................................... 14 
Partners: ................................................................................................................................ 14 
Sample Size Calculations ........................................................................................................ 14 
Surgeon Inclusion Criteria ...................................................................................................... 14 
Surgeon Exclusion Criteria ...................................................................................................... 14 
Patient Enrolment Criteria ...................................................................................................... 14 
Patient Exclusion Criteria ....................................................................................................... 15 
Intervention........................................................................................................................... 15 
Control .................................................................................................................................. 15 
Outcomes .............................................................................................................................. 15 
Main outcome ...............................................................................................................................15 
Secondary outcomes .....................................................................................................................16 
Informed Consent .................................................................................................................. 16 
Participant Withdrawal .......................................................................................................... 16 
Randomisation ...................................................................................................................... 16 
Pre-randomisation baseline assessment ......................................................................................16 
Randomisation ..............................................................................................................................17 
Baseline data ......................................................................................................................... 18 
The Intervention .................................................................................................................... 18 
Follow-up .............................................................................................................................. 20 
Analyses ................................................................................................................................ 20 
Statistical Analysis .........................................................................................................................20 
Cost Analysis .................................................................................................................................21 
Prevention of Bias .................................................................................................................. 21 
Potential Harms and Benefits of the Study .............................................................................. 21 
Potential Harms ............................................................................................................................21 
Potential Benefits ..........................................................................................................................22 
Benefits to the study participants ...........................................................................................................22 
General benefits ......................................................................................................................................22 

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Training Timetable ................................................................................................................. 22 
Project Management ...................................................................................................... 24 
Study Management ................................................................................................................ 24 
Trial Steering Committee........................................................................................................ 24 
Department resources, collaborators & contractual arrangements .......................................... 24 
Orbis International ........................................................................................................................24 
Beijing Tongren Hospital ...............................................................................................................25 
Queen’s University Belfast ............................................................................................................25 
International Centre for Eye Health (London School of Hygiene and Tropical Medicine) ...........25 
Project leadership plan (for consortiums) ............................................................................... 25 
Research PI team professional history/biography ................................................................... 25 
Ethical Considerations .................................................................................................... 26 
Ethical Approval ..................................................................................................................... 26 
Patient and Surgeon Informed Consent .................................................................................. 26 
Patient Privacy ....................................................................................................................... 26 
Participant Information .......................................................................................................... 27 
Budget and Justification.................................................................................................. 27 
Dissemination of Results and Publication Policy .............................................................. 28 
Appendices ..................................................................................................................... 29 
Appendix 1 Informed Consent Forms and Participant Information Sheets ................................ 29 
Appendix 2 Budget ................................................................................................................. 29 
Appendix 3 OSCAR and Simulation-OSSCAR ............................................................................ 29 
Appendix 4 Patient Consent to Clinical Photography ............................................................... 29 
Appendix 1a  
 Participant Consent Form ..................................................................... 30 
Appendix 1b  
Participant Information Sheet – SICS Training ........................................ 32 
Appendix 3a.    
ICO SICS OSCAR ................................................................................. 40 
Appendix 3a.    
ICO SICS OSCAR Chinese .................................................................... 40 
Appendix 3c.   
SICS Simulation-OSSCAR ....................................................................... 41 
Appendix 4.  
Consent to Clinical Photography Form ................................................... 42 
References ..................................................................................................................... 43 
 
 
 

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Glossary of Abbreviations 
 
BOOST  
Better Operative Outcomes Software Tool 
CF 
 
Counting fingers 
COS 
 
Chinese Ophthalmic Society 
CPD 
 
Continuing professional development 
CSR 
 
Cataract surgical rate 
FRCOphth 
Fellow of the Royal College of Ophthalmologists (UK) 
GCP 
 
Good Clinical Practice 
IAPB 
 
International Agency for the Prevention of Blindness 
ICEH 
 
International Centre for Eye Health 
ICC 
 
Intraclass correlation coefficient 
ICO 
 
International Council of Ophthalmology 
ITT 
 
Intention-to-treat 
LSHTM  
London School of Hygiene & Tropical Medicine 
LOCS  
Lens opacities classification system 
LMIC  
Low & middle income countries 
MD 
 
Medical Doctor 
MEd 
 
Masters in Education 
MOH  
Ministry of Health 
MOU  
Memorandum of Understanding 
MPH  
Masters in Public Health 
NEI 
 
National Eye Institute 
NY 
 
New York 
OLIMPICS 
Ophthalmic Learning & Improvement Initiative in Cataract Surgery 
OSCAR  
Ophthalmology Surgical Competency Assessment Rubric 
OSSCAR 
Ophthalmic Simulated Surgical Competency Assessment Rubric 
PCR 
 
Posterior capsule rupture 
PI 
 
Principal investigator 
POD 
 
Post-operative Day 
QUB 
 
Queen’s University Belfast 
PRECOG 
Prospective Review of Early Cataract Outcomes and Grading Study 
RCT  
 
Randomised controlled trial 
SDP 
 
Sustained deliberate practice 
SICS 
 
Small-incision cataract surgery  
SOS 
 
Simulated ocular surgery 
STEER  
Orbis/Chinese Ophthalmic Society Rural Training Program 
TREE  
Translational Research for Equitable Eyecare 
UK 
 
United Kingdom 
USA 
 
United States of America 
VA 
 
Visual acuity 
VFQ 
 
Visual Functioning Questionnaire 
VL 
 
Vitreous loss 
WHO  
World Health Organisation 
 
 
 

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Keywords 
 
Simulation, Surgical Education, Training, China, Cataract, Ophthalmic, Randomized Trial, 
Model Eye 
 
 
 

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General Information 
 
Project Title 
 
A Randomized Trial of Low-Cost Model Eyes for Cataract Surgical Training of Rural Chinese 
Ophthalmologists: The China OLIMPICS (Ophthalmic Learning & Improvement Initiative in 
Cataract Surgery) Trial 
 
  
 
Identifying numbers 
Beijing Tongren Hospital Research Ethics Committee: TRECKY2017-046 
Queen’s University Belfast Research Ethic Committee: 
London School of Hygiene & Tropical Medicine:  
ClinicalTrials.gov ID: NCT03458442 (date of registration: 1 March 2018) 
 
 
Principle Investigator 
 
Principal Investigator (Orbis, QUB) – Prof Nathan Congdon  MD  MPH 
 
Ulverscroft Chair of Global Eye Health, Queens University Belfast, University Rd, Belfast, BT7 
1NN, UK; Director of Research, Orbis, International, NY, USA 
 
Mobile/Cell:  UK  +447748751393 
 
 
 
 
Coordinating Research Institutions 
Beijing Tongren Hospital, Beijing, China 
Queen’s University Belfast, UK 
International Centre for Eye Health, London School of Hygiene & Tropical Medicine, UK 
 
 
Collaborating Training Institutions  
 
Zhongshan Ophthalmic Center, Guangzhou, China 
 
Sichuan Provincial People's Hospital, Chengdu, Sichuan, China 
 
Jinan Hospital, Jinan, Shandong, China 
Hebei Provincial Eye Hospital, Hebei, China  
 
 
 
 

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Study Sponsor 
Queen’s University Belfast is the main research sponsor for this study.  For further 
information regarding the sponsorship conditions, please contact the Governance, Ethics & 
Integrity Team, Queens University, University Road, Belfast, BT7 1NN, Northern Ireland, UK 
• 
+44 (0)28 9024 5133 
• 
researchgovernance@qub.ac.uk 
 
 
Study Funders 
Lions Club International Foundation, IL, USA 
 
 
 
 
 

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Executive Summary 
 
The leading cause of blindness in China and the world more generally is un-operated cataract. 
Despite notable efforts on the part of the Chinese government, China’s cataract surgical rate 
(1400/million/year in 2015) remains lower than that of many of its poorer neighbours, such 
as India (6500)1 and Vietnam (2250)2. An important reason is the unavailability of trained 
surgeons. Although China has over 36,000 ophthalmologists, only a third are capable of 
performing independent cataract surgery. This shortfall is due in large part to a lack of hands-
on training opportunities. For instance, a recent survey of residents at China’s top-ranked 
resident training programs found that the median number of independent cataract surgeries 
performed was actually zero.3 The problem persists after formal training is completed and 
looks set to worsen as experienced surgeons retire: in recent years, <5% of cataract surgeries 
were performed by doctors aged 24-43 years. The problem is particularly acute in rural areas, 
where hands-on training opportunities for young ophthalmic surgeons are even rarer. One 
reason is safety concerns on the part of patients and senior doctors in entrusting operations 
to young surgeons. 
 
New training models for cataract surgery are needed which can safely and efficiently support 
trainees during the transition from novice to competent surgeon. Simulation-based surgical 
training, using high-fidelity, inexpensive, re-usable model eyes have been successfully piloted. 
We now propose to study these in a randomized trial comparing a programme that combines 
training using these model eyes and training using traditional techniques versus traditional 
training alone, to assess the impact on quality of surgery (assessed by masked grading of 
videos using the ICO OSCAR system), visual acuity and cost-utility outcomes. We hypothesize 
that the hands-on training with the model eyes will be a valuable addition to the more didactic 
standard training. 
 
The costs of our research will be minimised by piggybacking on an on-going collaborative 
program between Orbis International, the Chinese Ministry of Health (MOH), Chinese 
National Blindness Prevention Committee and Tongren Hospital (one of China’s largest and 
best-respected eye hospitals), which will train 120 rural cataract surgeons at 60 county 
hospitals in 6 provinces.  Our collaboration involves internationally-respected vision research 
teams at ICEH, Queen’s University Belfast and Tongren; while offering opportunities for scale-
up and engagement with Chinese policy makers at the highest level.  This collaboration 
provides an excellent setting to assess whether model eye training can contribute to standard 
surgical training.  
 
A successful trial proving the training benefits of inexpensive model eyes will make a unique 
contribution to building the capacity to manage China’s leading cause of blindness, thus 
furthering the aims of SightFirst and the Chinese MOH, while improving the lives of Chinese 
people dwelling in low-resource areas. 
 
 
 
 
 
 

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Background Literature Review  
 
Some 90% of preventable blindness occurs in the developing world,4 and with the aging of 
populations globally, there is a rapidly increasing demand for well-trained ophthalmic 
personnel. Data from the International Council of Ophthalmology (ICO) reveal a shortage of 
ophthalmologists, with a shortfall predicted in both low income and developed areas.5 
 
China accounts for 18% of the world's blind, with an estimated 5 million people who have lost 
the ability to self-care, half of them due to un-operated cataract.6 7 The Chinese Ministry of 
Health has made it a priority to tackle preventable blindness nationally, but the estimated 
number of cataract operations performed annually (360,000) falls short of the number of 
people becoming blind each year from cataract (400,000).6 The cataract surgical rate (CSR) is 
the number of cataract operations per million population per year. China's cataract surgical 
rate of 1400 is far lower than that of India (6500)1 and Vietnam (2250),2 both of whom have 
lower per capita incomes.8  
 
In addition to the lack of access to affordable rural eye care9 and the aging Chinese 
population,10 an important cause of China's cataract problem is the lack of qualified 
ophthalmologists. Fewer than one third of the estimated 36,000 ophthalmologists in China 
perform cataract surgery,11 most concentrated in urban settings. Surgical quality among those 
who do operate is not always optimal, especially in rural areas.12 
 
The lack of hands-on training opportunities is an important barrier to achieving the Chinese 
government’s goal of increasing cataract surgical capacity. A recent survey of residents at top-
ranked training programs in China and Hong Kong found that the median number of cataract 
procedures performed during residency by Chinese trainees was 0 (compared to 100 for Hong 
Kong)3; falling well below mandated training minimums for other countries, such as 80-90 for 
Singapore and the United States and 350 for the United Kingdom. This problem of inadequate 
training opportunities persists after formal residency training is completed: in recent years, 
doctors aged 24-43 years performed <5% of operations across several specialities including 
ophthalmology, with two-thirds to three-quarters done by doctors over 50 years of age.13 The 
need to train a new cadre of young eye surgeons is particularly compelling in view of the fact 
that doctors at most of China’s largest hospitals are civil servants, with a mandatory 
retirement age of 60. The problem has been ascribed in part to the unwillingness of senior 
physicians to accept responsibility for complications caused by junior surgeons.13   
 
Alternative training models that can safely build capacity among younger cataract surgeons 
are sorely needed. The problem is particularly profound in underserved rural areas. The 
Chinese Ministry of Health and Chinese Ophthalmic Society (COS) recently invited Orbis 
International to collaborate with Tongren Hospital, one of China’s leading training centres, to 
carry out a project establishing a training curriculum for rural surgeons, which will include 
cataract surgical training for 120 rural doctors at 60 county hospitals in 6 provinces. Because 
of the opportunities it offers for scale-up and engagement with policy makers at the highest 
level, this Orbis-COS project has been chosen as the platform for the proposed research. 
 
Cataract Surgery 
 

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The procedure of sutureless scleral-tunnel small-incision cataract surgery (SICS) is one of the 
most commonly performed cataract surgery procedure in China, and is a main standard of 
care.  The technique uses a smaller wound compared to the older technique of sutured extra-
capsular cataract extraction.  There is less post-operative astigmatism, and fewer suture-
related problems for SICS. The clinical outcomes of phacoemulsification cataract surgery and 
sutureless extra-capsular manual SICS are comparable.14-17 SICS is an appropriate, safe, and 
affordable technique. 
 
The primary outcome of cataract surgery is an improvement in visual acuity (VA). This can be 
measured without refractive correction (unaided), or with spectacle correction (best-
corrected).  It can be measured for distance (usually 6 metres) or near (usually 30cm). It is 
often very difficult, unrealistic, and expensive to measure post-operative visual acuity a few 
weeks after cataract surgery in rural LMIC settings due to the logistics of bringing the patient 
back to the hospital.  Furthermore, there is evidence that day-one post-operative VA is a very 
good predictor of final VA.18  It is critical for surgeons to collect and analyse their own cataract 
surgical outcomes, as there is clear evidence that such monitoring and personal reflection 
improves surgical quality and outcomes.19 Tools for monitoring the outcomes and quality of 
cataract surgery have been developed, including post-operative VA, surgical complications, 20 
and the ICO OSCAR (Ophthalmology Surgical Competency Assessment Rubric).21 22 
 
Complication rates vary for cataract surgery, depending on co-morbidity, the experience of 
the surgeon, the maturity of the cataract, and the technique used. Rates of complications 
(posterior capsule rupture (PCR) or vitreous loss (VL)) vary from 1.92% to 6%.15 16 23  The WHO 
recommends aiming for a complication rate (PCR rate) of <5%.   
 
Surgical Education and Simulation 
 
It is of course of benefit to patients, trainees and trainers if simulation in surgical training 
offers and enables an accessible, safe, and reproducible method of learning surgical skills and 
procedures outside of the stress of the operating theatre.  However, despite these explicit 
and implicit benefits, and the great enthusiasm surrounding simulation in surgical and 
certainly ophthalmic surgical training, a question remains: are the skills obtained transferable 
to theatre? Simply put, does practicing eye surgery on a simulator only make a trainee better 
at operating on a simulator, or does it make him/her better in the live-surgical setting too?  
This ‘predictive validity’, being the transfer of skills learnt in a simulation environment to live 
surgery, is challenging to measure. 
 
Intensive simulation-based surgical education has been shown to rapidly increase surgical 
skills, decrease complication rates, provide a safe and relaxed environment to learn in, and 
enable sustained deliberate practice.24 However, this has not yet been demonstrated for 
ophthalmic surgical training in the context of a randomised trial.25 
 
Artificial eyes made from plastic and other synthetic materials have been used and developed 
over the past decade for ophthalmic simulated training.  In the UK, Phillips Studio in Bristol 
have developed artificial eyes for use in training in a number of ophthalmic surgical 
procedures, including SICS and trabeculectomy.26 ‘Kitaro DryLab’ is a tool to teach and learn 
some steps of cataract surgery, including the capsulorrhexis.  It is portable, and can be used 

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on a desktop, and without the need for an operating microscope (Frontier Vision Co. Ltd., 
Hyogo, Japan).  
 
In a major systematic review, a team from Denmark screened over a thousand papers, and 
studied 118 trials involving simulation-based training or assessment of ophthalmic surgical 
skills among health professionals.25  They concluded that “using simulation models without 
knowledge of reliability, validity and efficacy may compromise patient safety, especially if the 
trained skills do not correlate with the skills needed for real-life performance”. Through the 
use of state-of-the art frameworks for assessing the quality of trials, including a modern 
unified framework consisting of five sources of validity and a four-level assessment of the 
efficacy of simulation training programmes, they found the overall evidence for the use of 
simulation-based training or assessment in ophthalmology to be poor.  Only two of the trials 
investigated transfer of skills into the operating theatre, and only four evaluated the effect of 
simulation-based training on clinically-relevant outcomes. More rigorous educational 
research investigating the validity, reliability and efficacy of simulation-based ophthalmic 
surgical training is needed.  
Rationale 
 
The leading cause of blindness in China and the world generally is un-operated cataract. 
Despite notable efforts on the part of the Chinese government, China’s cataract surgical rate 
(1400/million/year in 2015) remains behind that of many of its poorer neighbours.  An 
important reason is the unavailability of a large enough number of trained surgeons. A recent 
survey of residents at China’s top-ranked resident training programs found that the median 
number of independent cataract surgeries performed was zero.3   
 
Therefore, the huge need for eye surgery requires effective and efficient methods to meet 
the need to train eye surgeons. One way to achieve this might be through simulation-based 
surgical education, which has been shown to rapidly increase the rate of learning of surgical 
skills, decrease complication rates, and provide a safe and calm environment to learn in.24 
However, this has not yet been robustly tested or proven for ophthalmology surgical 
training.25  
 
 
 
Project aims 
 
The aim of the proposed project is to provide an evidence base for a novel approach to 
cataract surgical training at the county-hospital level in China: the use of low-cost, high-
fidelity model eyes. Thus, project aims are very tightly aligned with key SightFirst priorities in 
China: improving cataract surgical capacity, developing new training models and 
strengthening county-level facilities. 
 

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Objectives 
 
This study will assess whether the addition of simulation-based ophthalmic surgical education 
using bespoke artificial eyes is superior to standard conventional training alone; with regard 
to the initial acquisition of surgical competence, and surgery-specific outcomes (post-
operative visual acuity).  The outcomes will include measures of both surgical competence 
and surgical quality. 
 
The overall purpose of this research is to develop the evidence base to guide efficient, high-
quality skills development in ophthalmic surgical training in China, which can then be scaled-
up to include other regions. The evidence base to be developed could inform the planning 
and implementation of ophthalmology surgical training programmes globally. 
 
 
 
 

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Methodology 
 
Study Design: Randomized controlled trial of an educational intervention. 
 
Study Population: Cataract surgical trainees learning to perform small-incision cataract 
surgery (SICS) in the Orbis/Chinese Ophthalmic Society Rural Training Program (STEER). (This 
is a currently funded Orbis project, thus reducing the costs for this randomised trial.) 
 
Partners: Orbis International and Queen’s University Belfast (Congdon is affiliated with both); 
Tongren Hospital and the Chinese National Committee for the Prevention of Blindness (Wang 
heads both); and International Centre for Eye Health at the London School of Hygiene & 
Tropical Medicine (Dean, Burton) 
 
Sample Size Calculations: Based on OSCAR (ophthalmology surgical competency 
assessment rubric) scores for different surgical steps among SICS trainees at Aravind, India: 
14 doctors in each of two groups operating on 10 patients each (total 280 surgeries) would 
allow for detection of a difference in mean OSCAR scores (across all steps) of 1.0 (point per 
set) between groups with a power of 0.9, alpha-error of 0.05, a standard deviation of 1.0 for 
scores, and an ICC of 0.57 for scores across cases within surgeon.   The ICC value comes from 
our review of SICS cataract surgical training assessed using OSCAR in other Orbis training 
programs.  (As this main outcome will be captured during surgery, there is no need to inflate 
our required sample size estimate to allow for loss to follow-up). 
 
A total of 34 participants has been selected, to allow for a 15% attrition rate. 
 
ICO-OSCAR scores cover 19 categories, with each category score ranging 0 to 5, and therefore 
with an overall 0 to 95.  An example of a 1.0 point difference within the category, 
“Conjunctival and Corneal Tissue Handling” is for a Competent score (score = 5) the “tissue is 
not damaged nor at risk by handling,” while for an Advanced Beginner score (score = 4), 
“tissue handling decent but potential for damage exists.”      
 
Surgeon Inclusion Criteria:  
• <20 complete SICS cases performed lifetime 
• 25-50 years of age 
• Completed ophthalmic training 
• Will have opportunity to carry out independent SICS surgery after training 
 
Surgeon Exclusion Criteria:  
• Already capable of performing independent intra-ocular surgery of any kind 
• No opportunity to perform cataract surgery after training 
• Unwillingness to discuss surgical training with colleague from other randomised group  
 
Patient Enrolment Criteria:  
• Cataract in one or both eyes felt to be visually significant in the opinion of the patient 
and operating ophthalmologist. 
 

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Patient Exclusion Criteria:  
• Fellow eye has an irreversible cause of visual impairment 
• Any prior ophthalmic surgery in the proposed operative eye 
• Any co-morbid condition in the operative eye likely to impact post-operative visual 
acuity negatively (conditions only detected on post-operative examination would also 
lead to retrospective exclusion) 
 
Intervention: Standard surgical training (as described below for “Control”) plus a new, 
bespoke simulation-based training scheme using low cost, reusable model eyes combined 
with practical surgical exercises, developed in Africa by ICEH collaborator Dean. See page 17. 
 
 
Control: Standard surgical training (without the bespoke training scheme that uses 
simulation and model eyes) in the ORBIS-COS administrated STEER project, mentioned above.  
Trainees complete 2-4 weeks of didactic lectures, surgical observation, and wet-lab training 
at a provincial training centre with a minimum of 50 pig eye wet-lab simulations per trainee.  
After observed mastery of wet-lab pig eyes, trainees then perform hands-on training in 
County level hospitals.  The hands-on training pairs a surgeon from the training centre who 
travels to the county level hospital to mentor the trainee through a minimum of 30 assisted 
surgeries, and 50 ‘independent’ surgeries under supervision. This project and its cataract 
surgical training protocol have been approved by the Chinese National Blindness Prevention 
Committee, who are essential partners.   
 
Outcomes 
 
Main outcome: Mean video grade of the first 10 successive supervised or assisted SICS cases 
(with patient consent) for each surgeon, using ICO-OSCAR. Two approaches to determine 
mean video grade will be employed to account for the variation in the number of surgical 
steps performed by trainees. Variation either arises from individual competence, with the 
assumption that more competent surgeons are given a larger role during surgery, or from 
the teaching style of different mentors, with an emphasis on conservative training.  
 
Both approaches are equally significant for determining the main outcome, and differ solely 
in the number of steps graded.   
• Mean video grade across all surgical steps of the first 10 successive supervised or 
assisted SICS cases (with patient consent) for each trainee surgeon, using ICO-
OSCAR. This approach penalizes surgeons for executing less steps, assigning a score 
of 0 for steps not performed.  
• Mean video grade across all trainee-completed steps of the first 10 successive 
supervised or assisted SICS cases (with patient consent) for each trainee surgeon, 
using ICO-OSCAR. This approach scores surgeons only on surgical steps they 
performed in consideration of the variation in mentors’ teaching styles.  
 
 

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The graders are masked to surgeon/patient identity, using a file-sharing platform to transfer 
videos to graders and collate grading information.21 22 27  These 10 cases will be the first 10 
out of 30 cases completed under the supervision of the STEER traine.   
 
Secondary outcomes:  
• 
Mean presenting logMAR visual acuity on post-operative day (POD) 1 of ten successive 
cases with patient consent per surgeon (measured using the BOOST [Better Operative 
Outcome Software Tool] application.28 
• Mean improvement in lines of visual acuity in operative eye at POD 1. 
• Cost per trainee in each group. 
 
Informed Consent 
Potential participant trainees will be informed of the training opportunity and this research 
study. Heads of Training Centres will be involved in the process and are co-investigators in 
the trial. 
 
Surgeon participants will be informed in detail about the nature of the education-intervention 
study; all surgeons participating will be free to leave the study at any time.  See Appendix 1a 
and 1b for detailed Information and Consent Forms. Surgeons who decline to take part in the 
study will be offered the standard STEER surgical training package without the bespoke 
training scheme that uses simulation and model eyes. Each participant eye surgeon attending 
the 2 to 4-week training and involved in this educational-intervention research will be invited 
to read and sign a consent form (Appendix 1). 
 
Patient participants will be informed that the outcomes of their surgery will be recorded as 
per normal good clinical practice and standard care.  Informed consent to video record their 
surgery will be obtained.  A standard consent form (Appendix 4), similar to local consent forms 
that indicates permission to use standard clinical photography will be used.  This form will 
indicate that, as part of an educational randomised control trial, some surgeons received 
additional training.  This form will be read to patients in Chinese, if they are unable to read it; 
and they will be invited to sign.  The individual seeking consent should not know which 
randomisation group the surgeon is in.  
 
 
 
Participant Withdrawal 
Surgeon participants, in either the ‘intervention’ or ‘control’ group, are free to leave the study 
at any time. If this is the case for any participant, no effort will be made to recover any costs 
incurred or equipment provided. Data collected up to the point of withdrawal of consent will 
have been anonymised and securely stored, and will still be held and included in data analysis.  
 
 
Randomisation 
Pre-randomisation baseline assessment 
Following consent, participant surgeons will be evaluated. This will include evaluation of 
previous surgical experience, and introduction to the ICO OSCAR.29 They will then be assessed 

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using the baseline Simulation-OSSCAR (see Appendices 3a and 3b). This will involve three 
simulation procedures (these will be recorded, anonymised, and remotely assessed using the 
Simulation-OSSCAR). This provides the baseline score for all participants: intervention and 
control.  
 
 
Randomisation (stratified blocked randomization):   
 
 
Participants who have reached the appropriate inclusion and exclusion criteria for the trial 
will be eligible for randomisation to ‘intervention’ or ‘control’. 
 
Eligible trainees completing baseline data collection will be enrolled into the study and 
stratified into 10 groups* according to their training center and hospitals (home facilities). 
The hospitals with only one participant are combined to form a mixed group. Participants in 
each of the 10 stratified groups will be assigned at random to one of the study arms as shown 
in the following figure.   
 
 
An independent statistician having no contact with participants will generate the 
randomization sequences (lists) using a computer system that is inaccessible until after 
recruitment. The random sequence includes three types: (1) A list of the mixed hospitals with 
only one participant; (2) A number of lists of the hospital with paired participants (3) Individual 
list(s) of the hospitals with more than two participants. Each random sequence comprises of 
sequence numbers and their corresponding codes (e.g. two letters plus a 4-digit number). 
Codes are used to represent the Intervention or Control group; a codebook is created for 
decoding the group allocations. 
 
To preserve allocation concealment, a two-step procedure will be used for random allocation 
in each training center. 
 
Step 1: Project manager (PM) sends randomization sequences to the Quality Control officer 
(QCO). QCO assigns a code to each participant from the randomization sequences. QCO 
update the random lists with participant’s names and send it to PM. At the end of this step, 
neither the QCO or participants know what group the codes refer to.  
 
Step 2: As soon as receiving result file from QCO, PM checks the codebook, update the file 
with participant’s names and send it back to QCO. QCO allocates the participants into control 
and intervention groups and completes the random allocation. 
 
The participants will know their group assignment. However, the staff(s) grading video 
recordings of assessments will be masked by having a randomized number assigned to each 
video. 
 
 
 
 

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Baseline data: 
• 
Patient 
o Age/Sex 
o Baseline uncorrected and best-corrected visual acuity in operative eye 
o LOCS III cataract grade 
o Result of full ocular examination including test for afferent pupillary defect and intra-
ocular pressure, with subsequent dilation of the pupil and B-scan in the event of 
inadequate visualization of the fundus 
 
• 
Physician 
o Age/Sex 
o Presenting and best-corrected visual acuity in both eyes (near and distance) 
o Years of ophthalmic practice 
o Previous number of independent cataract surgeries performed (SICS and total) 
o Mean video grade across all steps on 3 successive SICS cases using ICO OSSCAR 
(Grader masked to surgeon/patient identity) 
 
 
The Intervention 
 
All participants in both intervention and control groups will undertake the 2-4 week Orbis-
COS STEER training course. This course will consist of didactic training, observation as well as 
a minimum of:  
1) wet lab training with 50 pig eyes  
2) assisting 30 surgeries, finishing one of more steps of the procedure, and 
3) 50 independent operations under supervision. 
 
Participants in the intervention group will be introduced to a variety of simulation-based 
surgical training techniques over 2 to 4 weeks. This additional training will involve a total of 
approximately 16 hours of video-based presentations, practical SICS procedures on model 
eyes, trainee feedback, and self-assessment of surgical performance using the simulation-
OSSCAR scoring system. Specifically, this will involve breaking down the SICS cataract surgery 
procedure into stages. At each stage surgeons will be presented background knowledge and 
then practice that stage repeatedly using simulation. This sustained deliberate practice will 
be an enhancement to the STEER course, and not as a replacement of any part of the 
educational content.  Within the first week of the course, ‘intervention’ arm participants will 
be introduced to the artificial eyes, practice the cataract surgery procedure using the 
Simulation-OSSCAR as a learning tool, and be provided with ongoing feedback. (See also 
Standard Operating Procedures (SOP) 9 through 19 for Model Eye Training).   
 
It is excepted that surgeons will independently complete 8 SICS procedures by the end of the 
training period.  The first two simulation SICS procedures on model eyes will be performed 
under supervision of the consultant trainer.  The fourth and eighth SICS procedure will be 
recorded, uploaded to Cybersight, and assessed by PI Dr Will Dean who will provide feedback 
to the trainee. 
 
During this time, trainees in the control group are at liberty to spend time as they please.   
 

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China-OLIMPICS Trial Intervention Objectives and Timetable 
 
 
 
 
Follow-up 
 
Participant Follow-up schedule: 
Data collected at follow-up in the County Hospital: 
• 
Surgical recording of ten live SICS procedures (supervised by the trainer). 
 
Patient Follow-up schedule: Post-op Day 1 
Data at follow-up: 
• 
Uncorrected and best-corrected visual acuity in operative eye (post-operative day (POD) 1) 
• 
Ocular examination of operative eye with dilation of pupil to detect any co-morbidity 
undetected at baseline examination (POD 1) 
 
 
Analyses 
 
Statistical Analysis 
 
• 
Mean OSCAR grade for 10 consecutive consenting patients for each surgeon, comparing 
Intervention and Control Groups, with and without adjustment for baseline surgeon and 
patient factors. Each surgeon will have two mean OSCAR grades, one based off scores on all 
surgical steps and the other based off scores on trainee-completed steps, and they will be our 
co-primary outcomes. GEEs (generalised estimating equations) will be used for repeated 
measures analysis of the OSCAR scores. 
• 
Mean presenting logMAR visual acuity on POD 1 for ten consecutive consenting patients per 
surgeon, comparing Intervention and Control Groups, with and without adjustment for 
baseline surgeon and patient factors. 
• 
Mean improvement in lines of visual acuity in operative eye at POD 1, for 10 consecutive 
consenting patients per surgeon, comparing Intervention and Control Groups, with and 
without adjustment for baseline surgeon and patient factors. 
 

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Cost Analysis 
 
A cost-utility analysis will be conducted.  This will be cost per trainee in each group.  
 
 
Prevention of Bias 
 
It is accepted that there will be variability in individual participants’ inherent or natural 
surgical aptitude.  In order to attempt to reduce the effects of this, the two groups will be 
balanced with regard to the baseline OSCAR scores of participants, and their total number of 
previous surgical cases. This however will only occur in final analysis, and not before 
randomisation or training. 
 
All efforts will be made to standardise the training offered to the ‘Intervention’ participants.  
The intense simulation course will be held in the same Training Centres.  The training will be 
conducted by experienced trainers who have undertaken a specifically designed ‘Training the 
Trainers’ course.  All recordings of surgical procedures will be performed using the same 
recording system.  
 
Video recordings of procedures will be allocated a random 7-digit number, and subsequently 
stored onto an encrypted computer, and a separate encrypted hard drive.  This random 
number will be the only identifiable information available when the simulation/surgical 
procedure is assessed, thus masking the assessor to the participant’s randomised group.  
 
It is recognised that surgical education is complex and multi-faceted.  However, every effort 
will be made to reduce ‘contamination’ bias.  Participants will sign an informed consent form 
detailing that they will in no way share any of the details of the course or educational 
intervention with any surgeon who is not known to be in the same randomised group as 
themselves; for a minimum of six months following the end of the training programme in 
Tongren.  
 
The PIs and co-investigators declare that they have no financial or other conflicts of interest 
that are relevant to this randomised trial. 
 
 
Potential Harms and Benefits of the Study 
 
Potential Harms 
There are no clinical harms from the study protocol itself, as all the intervention training is 
using simulation.  No patients are involved in any of the training in the intervention group 
and training in the control group is using standard methods as described above, approved 
by the Chinese National Blindness Prevention Committee.  Patients are involved only as part 
of regulated and accredited post-graduate clinical and surgical practice within the 
collaborating tertiary training institutions and County level hospitals, and will undergo a 
separate, standard surgical informed consent process for any potential harms that might 
arise from their operations.  Operations taking place in the STEER project are part of this 

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previously-approved service delivery project, and as such are not being done as part of the 
OLIMPICS research protocol. 
 
With regard to risk of failure of the trial, these include the below possibilities: 
 
• 
Trainees not being available for enrolment 
• 
No patients being available in hospital 
• 
No or very few patients being enrolled for video assessments   
 
 
Potential Benefits 
Benefits to the study participants 
The surgeon participants in both groups (intervention and control) of the randomised trial will 
receive the Orbis-COS training course. Surgeons who decline to take part in the study will be 
offered the standard surgical training package without the bespoke training scheme that uses 
simulation and model eyes. 
 
Participants in the intervention group will also receive simulation-based surgical training. This 
is not designed to replace any standard training, but to augment it.   
 
An important element of ‘training-the-trainers’ is included in the study.  After the start of the 
study, trainers from collaborating institutions will be invited to a Training-the-Trainers course, 
which would benefit them as Surgeon Educators.  
 
 
General benefits 
The results of a successful trial would have major implications in augmenting and streamlining 
ophthalmic surgical education, and potentially changing the way ophthalmologists approach 
initial surgical training.  Additionally, this study could reduce patient complications while the 
trainee eye surgeon moves from ‘novice’ to ‘competent’.   
 
Finally, the evidence provided from this study could influence investment in surgical training 
units throughout China, and beyond.   
 
 
 
Training Timetable 
 
The GANTT chart below illustrates major milestones and deliverables. 
 
 
 
 
 
 
 
 

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Project Management 
 
Study Management 
Overall study management responsibility lies with the Principal Investigator.  Three monthly 
Project Update Reports will be circulated to co-investigators. Six monthly reports will be sent 
to the major funder.  
 
 
 
Trial Steering Committee 
The members of the Trial Steering Committee include: 
 
Prof Wang Ningli, COS      
Prof Nathan Congdon, QUB, Orbis 
Dr William Dean, ICEH, LSHTM 
Christopher Magoon 
Prof Hu Ailian, Director China NCPB 
Dr Peter Xu     
Prof Mathew Burton, ICEH, LSHTM 
Dr Wen Qing 
Dr Tang Jianjun 
Prof Ciaran O’Neill 
Prof Mike Clarke 
Catherine Jan 
 
 
 
 
Department resources, collaborators & contractual arrangements 
 
Orbis International has already entered into a Memorandum of Understanding (MOU) with 
Beijing Tongren Hospital and the National PBL Committee to support their Rural Eye Health 
Team Training Program. Queen’s University Belfast (QUB) has also completed an MOU with 
Tongren over on-going research collaborations between Congdon and Wang. These existing 
relationships, and the various collaborations between Orbis and QUB arising from Congdon’s 
being employed by both organizations, will form the basis for the three-way contractual 
agreement (Orbis-Tongren-QUB) supporting the current study. Resources of the main project 
partners are outlined below. 
 
Orbis International: ORBIS International has worked in China since 1982, carrying out over 
200 projects in 25 regions, which have trained tens of thousands of health care workers and 
provided hundreds of thousands of sight-saving surgeries. Orbis’ particular strength in China 
lies in the area of surgical instruction, and the current study will capitalize on Orbis’ rural 
surgical training program in collaboration with Tongren and the National PBL Committee, 
which will equip 120 rural surgeons to perform independent cataract surgery. The project will 
also benefit from Orbis’ unique CyberSight training platform, which will allow surgeries to be 

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recorded by trainees and graded in masked fashion by experienced surgeons using existing 
Chinese-language software provided by Orbis. 
 
Beijing Tongren Hospital: Tongren is China’s leading clinical and research facility in the area 
of eyecare. Tongren will provide a PhD student under Congdon and Wang’s joint supervision 
to oversee quality control and adherence to the trial protocol in the project, and will also offer 
support for data entry. A statistician at Tongren will be supervised by Dr Wen Qing at QUB 
(see below) as part of building local capacity in clinical trials. 
 
Queen’s University Belfast: Congdon is the Director of Translational Research for Equitable 
Eyecare (TREE) at QUB, a leading global eye health research centre. This centre includes six 
senior researchers in eye health, and a staff of statisticians, health economists and program 
managers fluent in Chinese to support projects in China such as the proposed research. QUB 
will offer the time of Congdon, statistician Dr Wen Qing and health economist Dr Tang Jianjun 
in kind to the project. Dr Wen Qing will oversee the randomization, drafting of study forms 
and protocols and statistical analysis in the project. Dr Tang Jianjun will oversee the health 
economic analyses (training costs and cost per line of vision gained per patient). 
 
International Centre for Eye Health (London School of Hygiene and Tropical Medicine): ICEH 
is a global leader in research and training for the delivery of high-quality eyecare in low-
resource areas. Collaborators Dean and Burton have developed and refined a bespoke 
training course around low-cost, re-usable, high-fidelity model eyes, which will be the focus 
of the current research. Their course will have incorporated use of the Orbis CyberSight 
platform prior to beginning the project in China. Dean will travel to China to supervise 
translation of the model eye training protocol to a Chinese setting, and provide oversight to 
the Chinese teams on maintaining quality throughout the training process. 
 
 
Project leadership plan (for consortiums)  
 
As PI, Congdon will be responsible for coordination between teams at Orbis, QUB, Tongren 
and ICEH, and will also supervise the Chinese-speaking statistician Dr Wen Qing at QUB. Wang 
will be the lead investigator on the Chinese side, co-supervising the Tongren PhD student and 
statistician responsible for the project. The Orbis China team, led by Dr Peter Xu, will assist in 
coordinating the research with the existing Orbis-Tongren rural training project. Burton will 
coordinate work on the model eye training program at ICEH and its translation to the Chinese 
context. 
 
Research PI team professional history/biography 
Congdon, the Ulverscroft Chair at QUB, Professor at Zhongshan Ophthalmic Center in China 
and Director of Research at Orbis, is an international leader in global eye health research, with 
over 175 publications in journals including JAMA, BMJ and Lancet Global Health, and an h-
index of 35. He has received honours including a Chinese government Thousand Man Plan 
Award (one of very few non-Chinese recipients) and the Holmes Lecture, one of Asia’s highest 
blindness prevention awards. Congdon has been funded by WHO, World Bank, EC, MRC, the 
US NIH, USAID and Chinese and Hong Kong governments. His fluency in written and spoken 

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Chinese, 10-year history of collaboration with Wang, and key roles at both Orbis and QUB will 
help to cement collaboration in the project. 
 
Wang, President of China’s top-ranked hospital Beijing Tongren, is the acknowledged leader 
in public health ophthalmology in China. He has published over 220 SCI papers, and has been 
funded by nearly every Chinese government health research scheme. He designed and 
directed the Handan Eye Survey, still the standard reference for understanding blinding 
disease in rural China, which has led to over 40 publications. Wang is arguably the most 
influential ophthalmologist in China, as past president of the Chinese Ophthalmic Society and 
head of the National Blindness Prevention Committee. He has worked closely with Congdon 
and Orbis since 2006. 
 
Dean, a UK-trained ophthalmologist, has extensive surgical and training experience in the UK 
and in low and middle-income countries, having performed over 7000 cataract operations in 
Africa, the majority of them SICS. He has a Masters in Surgical Education (MEd) degree from 
Imperial College London, and is a current recipient of the Barry Jones Fellowship funded by 
the British Council for the Prevention of Blindness, to complete a PhD in simulation-based 
cataract and glaucoma surgical education in low-income settings in Africa. He led the 
development, piloting and refining of the simulation-based SICS training course and model 
eyes used in this current proposed study. His PhD supervisor is Prof Burton of ICEH/LSHTM, a 
leading researcher in alternative service delivery models to promote eye health in low income 
settings. 
Ethical Considerations 
 
Ethical Approval 
Approval will be sought from ethics committees at Queen’s University Belfast and Beijing 
Tongren Hospital, and Capitol Medical University. It is estimated that the approval process 
will require 2 months at Tongren and 3 months at QUB. This will be completed in parallel with 
other preparatory work, including finalization and on-line registration of the trial protocol, 
and preparation of study forms, and, therefore, will not delay the start of the trial. 
 
Patient and Surgeon Informed Consent 
 
See above section on “Informed Consent” 
 
Patient Privacy 
 
Patient participants will be informed that the outcomes of their surgery will be recorded as 
per normal good clinical practice and standard care.  Informed consent to video record their 
surgery will be obtained.  The surgery will be anonymised, and no patient identifiable 
information will be kept.  Patients have the right to refuse consent for video recording, and 
this in no way will affect their treatment or surgery plan.  Photographs or videos of patients 
are often a part of clinical practice, teaching, telemedicine, or research.  Patients will be 
invited to sign a standard consent form (Appendix 4).   

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Participant Information 
 
Each participant eye surgeon attending the six-week training and involved in this educational-
intervention research will be invited to read and sign a consent form (Appendix 1). There is 
no fee for the course and all educational materials are given free of charge.  
 
Participant trainees should understand that the course is for their personal educational 
benefit, and they give permission for anonymised data from the study to be published in peer-
reviewed literature as part of broader research into surgical training techniques. 
 
No personal identifiable information will be included at any stage.   
 
Interviews, opinions, video recordings of assessments, and surgical outcome data of the 
education and training will only be used for academic purposes. 
 
The training is as a boost to ‘standard training’, and not a replacement: none of the results of 
this study of training will form a part of the participants’ professional records. 
 
Surgeon participants are free to leave the study at any time. If this is the case for any 
participant, no effort will be made to recover any costs incurred or equipment provided. 
 
Trainee participants in the Control group will be offered exactly the same six-week training 
course as the Intervention group, only without the use of simulation practice with model 
artificial eyes. 
 
Patients with cataract are indirectly involved in this study.  However, cataract surgery 
conducted in this study by all participants (in both the intervention and control groups) is part 
of standard and regulated good clinical practice; and supervised by qualified and registered 
senior eye surgeons as per normal practice. 
 
Patient outcome data will be anonymised, no personal patient identifiable information will 
be made public, and no personal patient identifiable information will be made available to 
any of the Investigators outside of China.  Patients operated in both the Intervention and 
Control groups will be during normal standard training, and thus regulated by the Chinese 
Medical Board. 
 
The research adheres to the tenets of the Declaration of Helsinki. 
 
Budget and Justification 
 
Appendix 2 shows the associated budget.  The project and training involves consumables and 
equipment, and other administrative costs (including for ethical approval). 
 

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Dissemination of Results and Publication Policy 
Publication will be sought for the main trial report in a high-impact factor journal with an open 
access policy (relevant examples include BMJ, Lancet Global Health and Investigative 
Ophthalmology and Visual Science), so as to improve access to researchers and policy-makers 
in low and middle-income countries. 
 
Co-authorship of submitted and published articles will be evaluated as per internationally 
agreed research guidelines, such that authorship credit will be based on: 
 
1. Substantial contributions to conception and design, or acquisition of data, or analysis and 
interpretation of data; 
2. Drafting the article or revising it critically for important intellectual content; and 
3. Final approval of the version to be published. 
 
Authors should meet conditions 1, 2, and 3. 
 
 
 

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Appendices 
 
Appendix 1 Informed Consent Forms and Participant Information Sheets 
Appendix 2 Budget 
Appendix 3 OSCAR and Simulation-OSSCAR 
Appendix 4 Patient Consent to Clinical Photography 
 
 
 
 

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Appendix 1a  
 
Participant Consent Form   
 
The China OLIMPIC (Ophthalmic Learning & Improvement Initiative in Cataract Surgery) 
Trial: Randomised Controlled Trial Comparing Intense Simulation-Based Surgical Education 
for Cataract Surgery to Conventional Training Alone in China.  
 
Beijing Tongren Hospital, PRC 
Queens University Belfast, UK 
International Centre for Eye Health, London School of Hygiene & Tropical Medicine, UK  
 
 
I  ____________________________________________________________________ 
(name) have been invited to participate in a trial of surgical training, involving a six-week 
intense training and education course for cataract surgery in _________________  Hospital, 
and ongoing assessment for the following 6 months. I understand there is no fee for the 
course, and all educational materials are given free of charge. I understand that the course 
is for my personal educational benefit.   
 
Study Reference Number:  
 
 
 
 
 
 
Please initial box 
1. I confirm that I have read and understand the participant information sheet 
dated ......….. (version ............) for the above study.  I have had the opportunity 
to consider the information, ask questions and have had these answered fully. 
 
2. I understand that my participation is voluntary and I am free to withdraw at 
any time, without giving any reason, without training or legal rights being 
affected. 
 
3. I give my permission for anonymised data from this course to be published in 
peer-reviewed literature as part of broader research into surgical training 
techniques, including the placement of an anonymized data set in a data 
repository. 
 
4. I understand that no personal identifiable information will be included in 
any published output.   
 
5. I understand that interviews, opinions, or recordings of the education and 
training will only be used for academic purposes. 
 
6. I understand that no formal feedback will be given to any of my colleagues or 
surgical supervisors or colleagues. 
  
7. I understand that no data will be made available to work/training institutions 
or be used for any future job selection. 
  
8. I agree to anonymised video recording and assessment for ten surgeries 
following the training course. 
  
9. I commit to ensuring that all surgical outcome data for patients operated by 
myself (supervised or other) for SICS, that these data (day 1 VA and 
complications of PCR) are captured onto a recording sheet (with no patient 
identifiable data), and reported for ten cases following the training course. 
  

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10. I understand, agree, and wholly commit to NOT discussing or sharing any of 
the details in any way with colleagues in this study who were allocated to the 
other trial group for at least six months following the training course. 
 
  
 
 
 
 
Signed _______________________________________________    Date:  
____________________ 
 
 
 
__________________________________________________________ 
 
Countersigned by Investigator (Christopher Magoon) 
 
Principal Investigator (China) – Prof Wang Ningli     1    
Principal Investigator (Belfast) – Prof Nathan Congdon  MD  MPH2 
Principal Investigator (London) – Dr William H Dean  FRCOphth  MEd  MBChB  BSc3,4 
 
 
Co-Investigators 
 
Christopher Magoon5 
Dr Peter Xu6 
Dr Wen Qing 
Dr Tang Jianjun 
Prof Mathew Burton  PhD  FRCOphth3 
 
Any queries should be directed in the first instance to the Principal Investigator Prof Nathan 
Congdon:   ncongdon1@gmail.com 
 
Phone: UK +44              China +86 
 
 
 
Please refer to Participant Information Sheet (OLIMPICS Version 1.0) 
 
 
 

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Appendix 1b  
Participant Information Sheet – SICS Training 
The China OLIMPIC (Ophthalmic Learning & Improvement Initiative in Cataract Surgery) 
Trial: Randomised Controlled Trial Comparing Intense Simulation-Based Surgical Education 
for Cataract Surgery to Conventional Training Alone in China.  
 
Participant Information Sheet (OLIMPICS Version 1.0, 2.28.18) 
 
Beijing Tongren Hospital, PRC 
Queen’s University Belfast, UK 
International Centre for Eye Health, London School of Hygiene & Tropical Medicine, UK  
 
Principal Investigator (China) – Prof Wang Ningli      
Principal Investigator (Belfast) – Prof Nathan Congdon  MD  MPH 
Principal Investigator (London) – Dr William H Dean  FRCOphth  MEd  MBChB  BSc 
 
 
Introduction 
 
You are being invited to take part in an educational-intervention research study. Before you 
decide whether or not you will be a participant, it is important for you to understand why this 
research is being done and what it will involve.  
 
Please take time to read the following information carefully. Ask us if there is anything that is 
not clear or if you would like more information. 
 
This information sheet is designed to tell you everything you need to think about before you 
decide whether or not you agree to be in the study. It is entirely your choice.  If you decide to 
take part, you can change your mind later and withdraw from the study. The decision to join 
or not join the study will not cause you to lose any of your usual training opportunities within 
the ORBIS-COS Training Initiative. 
 
You can take a copy of this information sheet to keep. Do not sign the consent form unless 
you have had a chance to ask questions and get answers that make sense to you. By signing 
the consent form, you will not give up any legal rights. 
 
 
Do you have to take part in this study? 
No. You do not have to take part in this study. Even if you do not take part in this study, you 
will still be offered exactly the same training as per The Orbis-COS curriculum. 
 
 
Study Overview 
 
What is the study about? 
The aim of this study is to investigate whether the addition of simulation-based surgical 
education improves competence and surgical outcomes. All participants in the study will 

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receive the educational intervention of the six-week Orbis-COS course. Those allocated to the 
intervention group will receive this training and an additional element of learning and 
sustained deliberate practice using model eyes and simulation.  
 
Why have you been chosen?  
You are being invited to join the study because you are an ophthalmologist at one of the 
collaborating County level hospitals, and you may meet all the eligibility criteria. 
 
How many people are taking part in this trial? 
We plan to recruit 28 eye surgeons in total: 14 for the intervention training group (with model eyes 
and simulation) and 14 for the standard (control) training group. 
 
 
Procedures 
 
What will we ask you to do? 
 
Baseline assessment:  
We will ask you some basic questions about cataract surgery.  We will ask you about your 
previous surgical experience. 
     
Randomisation:  
Immediately after baseline assessment, we will randomise you to either the SICS 
“intervention” training group or the SICS “control” training group.  “Randomisation” means 
that you have an equal chance of being in either group, like flipping a coin. 
 
Educational Intervention:  
Once you are allocated to one of the groups, you will receive clear instruction on how the 
timetable will run. If you are allocated to the “Intervention” group, then you will be invited to  
the STEER Training Centre nearest you for a six-week training course (run by Orbis and the 
COS). If you are allocated to the “Control” group, then you will also be invited to the same 
Training Centre for a six-week training course (run by Orbis and the COS). 
 
Follow-up assessments: 
We will revisit you at your hospital after the training course. We will ask you to video record 
the performance of ten SICS procedures (which we will anonymise).  During the period after 
the course, we will arrange for you and nurses at your hospital to record and report all of the 
outcomes of ten consecutive SICS surgeries that you perform in your hospital (in terms of day 
1 visual acuity, and incidences of peri-operative complications of posterior capsule rupture), 
using a smartphone app called BOOST which we will provide for free.   
 
It is critically important to emphasise that you should not share any of the learning, lessons, 
materials or experiences in any way between colleagues who are in a different group to you 
for at least the first six months after all training courses have concluded.  If you feel this will 
not be possible, then please to tell us, and we will work with you to try to make this possible 
or, if necessary, to exclude you from this study.   
 

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What is the educational intervention that is being tested?  
The surgical education that is being is investigated is intense simulation-based surgical 
training.  This involves practicing with model artificial eyes during the six-weeks training 
course, and subsequent practice back home. No patients are involved in this additional 
training.  This simulation part of training is not meant to replace standard training, but to 
augment it. Both intervention and control groups will subsequently conduct recorded 
surgeries on live patients as part of the standard training. 
 
 
Benefits 
What benefits are there to taking part in the study? 
You will be offered free surgical training course. All this training, and the expenses involved 
will be provided to you free of charge. No study has been done to investigate the efficacy of 
simulated ophthalmic surgical education for SICS to this level. You will be helping to resolve 
uncertainty about its potential benefits.  
 
Potential harms 
What are the potential harms of taking part? 
There are very low risks associated with participating in this study. You will be away from 
normal work for 2-4 weeks at the Training Centre. You may have colleagues with whom you 
will not be able to share (initially for at least six months) the learning from this educational 
intervention.   
 
What will happen to the assessment recordings, interviews, feedback, and surgical 
outcomes data you give? 
The video recordings will be made using the same instruments, and the same standard 
recording equipment.  They will also be anonymised so that none of your personal 
information will be identifiable.  These recordings will be stored on an encrypted hard drive 
in Beijing and Belfast, Northern Ireland, UK.  Interviews will be recorded and transcribed, 
anonymised, and thematised: again, no personal identifiable information will be kept.  
Surgical outcomes of your SICS procedures that you record for the ten cases will need to be 
documented in such a way so they do not include any patient-identifying information. Once 
these data are reported to the research team, none of your personal related information will 
be made available. Anonymised data will be including the placement of a anonymized data 
set in a data repository. 
 
Withdrawal from the Study 
You have the right to leave a study at any time without penalty. The researchers and sponsor 
also have the right to stop your participation in this study without your consent if, for example: 
• 
They believe there has been ‘contamination’ between “Intervention” and “Control” individuals 
• 
You do not agree to any future changes that may be made in the study plan 
 
New Information 
What will we do if we find if one educational-intervention is better than the other? 
You will be informed if one training approach is found to be better than the other, and we will 
publish the results of the study (regardless of our finding) to help people making decisions 
about surgical training in the future. 

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Payment  
You will not be offered payment for being in this study.  
 
Costs 
There will be no costs to you for participating in this study. You will not be charged for any of 
the research activities. All transport, accommodation, meals, and materials will be provided 
free of charge. You will not receive any additional payments or per diems for participating, 
beyond your normal stipend or salary from your training unit. 
 
 
Confidentiality  
What will happen to the records/interview, and videos we keep of your (simulation) 
operations? 
All the information and videos we collect will be kept confidential. It will be kept securely and 
only the primary investigator, or expert markers will have access to it. A study number rather 
than your name will be used on study records wherever possible. Your name and other facts 
that might identify you will not appear when we present this study or publish its results. No 
information from this study will be placed into your ophthalmology training record.   
 
 
In Case of Complaint 
What if there is a problem? 
Any complaint about the way you have been treated during the study will be addressed. Please 
use the addresses below to contact the study coordinators.   
 
Who is sponsoring this study? 
The study is sponsored through Beijing Tongren Hospital and Queen’s University Belfast.   
 
Who has reviewed the study?  
This study was reviewed and approved by the Beijing Tongren Ethics Review Committee, and 
the Queen’s University Belfast Ethics Committee.  
 
 
Who is doing this study? 
The study will be coordinated by Christopher Magoon who is a Yale University graduate, and 
MD candidate at the University of Pennsylvania Perelman School of Medicine and has 
extensive experience of working in rural China, and public health. Co-coordinators include Dr 
Kang Mengtian, a resident trainee in ophthalmology at Tongren, and Tai Stephan, an expert 
in Monitoring and Evaluation at the Orbis International Beijing office.  
 
Professor Nathan Congdon, the Ulverscroft Chair at Queen’s University Belfast, UK, Professor 
at Zhongshan Ophthalmic Center in China and Director of Research at Orbis, is the Principal 
Investigator, along with Professor Wang Ningli, of Beijing Tongren, and Dr William Dean, who 
is completing a PhD in simulation-based cataract surgical education at the International 
Centre for Eye Health in London, UK.  
 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
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Contact Information 
How can you obtain more information about the study? 
If you have any questions about this study or your part in it, or if you have questions, concerns 
or complaints about the research more generally, contact Dr. Kang Mengtian, 
kangmengtian@163.com, +86 13581788600. 
 
 
 
 
You will be given a copy of the information sheet to keep. 
Thank you for considering taking the time to read this sheet. 
 
 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
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Appendix 2 
Budget 
 
Budget Category 
Itemised Costs of 
specific project 
activities 
Budgeted Spend (USD) 
6 
month
s* 
12 
month
s* 
18 
month
s* 
24 
month
s* 
TOTAL 
Target 
Target 
Target 
Target 
Target 
PERSONNEL (salaries, 
per diems, honoraria, 
etc.) 
  
  
  
  
  
  
  
Orbis CyberSight 
development of grading 
platform  
6,000 
  
  
  
6,000 
  
Patient baseline 
questionnaire 
collection: $10/patient 
* 280 patients 
400 
1,200 
1,200 
  
2,800 
  
Local post doctoral 
research coordinator 
Beijing Tongren (over 
the full period of 
project 
implementation) 
$875/mo 
(CNY6000/mo) * 18 
months 
1,750 
5,250 
5,250 
3,500 
15,750 
  
Data collection on 
visual acuity outcomes: 
$10/case X 280 cases  
400 
1,200 
1,200 
  
2,800 
  
Top-up fees for surgery: 
$20/case*280 cases 
800 
2,400 
2,400 
  
5,600 
  
Grading of 280 +56 
videos by senior 
cataract surgeons at 
$10/video  
960 
1,200 
1,200 
  
3,360 
  
Patient endline 
questionnaire 
collection: $10/patient 
* 280 patients 
400 
1,200 
1,200 
  
2,800 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
38 
  
Data entry for forms: 4 
forms/patient*280 
patients*$3/form 
  
  
  
3,360 
3,360 
  
Data analysis (Also 
includes support for 
form creation, creation 
of database and 
randomization process): 
Statistician $1300/mo 
(CNY9,000/mo) * 
100%time * 6 months 
3,500 
800 
  
3,500 
7,800 
Personnel Sub-total 
  
14,210 
13,250 
12,450 
10,360 
50,270 
  
  
  
  
  
  
  
EQUIPMENT 
(including 
consumables, rentals, 
etc. 
  
  
  
  
  
  
  
Model eyes (14 
surgeons*8 
eyes/surgeon*$60/ 
eye) Phillips 
6,720 
  
  
  
6,720 
  
Mannequins and 
mounts for model eyes 
Phillips 
2,400 
  
  
  
2,400 
  
Kitaro DryLab artifical 
eye system 
2,200 
  
  
  
2,200 
  
Zeiss Stemi 305 ECU 
microscopes for 
training on artifical eyes 
(4 * @ $2,000)  
8,000 
  
  
  
8,000 
  
Video cameras $800*5 
cameras 
4,000 
  
  
  
4,000 
  
Laptop@ $800 
800 
  
  
  
800 
Equipment Sub-total 
  
24,120 
0 
0 
0 
24,120 
  
  
  
  
  
  
  
TRAVEL 
  
  
  
  
  
  

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
39 
  
Travel to China for 
investigator Will Dean: 
$1500 return fare, $150 
hotel/night and 
$50/day food X 10 days 
3,500 
  
  
  
3,500 
  
Patients transport: 280 
patient*$15 each 
600 
1,800 
1,800 
  
4,200 
  
Travel to China for 
investigator Will Dean: 
$1500 return fare, $150 
hotel/night and 
$50/day food X 5 days 
  
  
2,500 
  
2,500 
Travel Sub-total 
  
4,100 
1,800 
4,300 
0 
10,200 
  
  
  
  
  
  
  
TOTAL PROGRAM 
COSTS 
  
42,430 
15,050 
16,750 
10,360 
84,590 
  
  
  
  
  
  
  
FACILITIES & 
ADMINISTRATIVE  
Indirect Costs 
2,375 
2,375 
2,375 
2,375 
9,500 
  
  
  
  
  
  
  
TOTALS 
  
44,805 
17,42
5 
19,12
5 
12,73
5 
94,090 
 
 
 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
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Appendix 3a.    ICO SICS OSCAR 
 
 
 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
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Appendix 3c.   SICS Simulation-OSSCAR 
 
 
 
 
 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
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Appendix 4.  
Consent to Clinical Photography Form 
Consent to Clinical Photography Form 
PATIENT INFORMATION 
Dear patients: 
             Hello! 
We are working on a scoring system for cataract surgeons' surgery skills and 
will need your permission to take pictures and videos of your eyes and the 
operation. By signing this informed consent form, you certify that you agree 
and know that your clinical information will be taken and recorded. 
You can refuse to have photographs or videos taken for any reason other than 
for your health records. This will not affect your treatment in any way.  
You have been asked to have medical video recordings taken. These will be for:  
Anonymous assessment of your surgery, as part of ongoing evaluation of 
eye surgery and surgery training. 
The videos of your surgery will not themselves be published or made 
available in any way to the public.    
You will be given information about how the recordings will be used and will 
be asked to sign a consent form.  
Further Information: If you have any further questions, please speak to your 
doctor.  
This leaflet is available in large print and other languages on request.  
Consent to Clinical Photography/Video and Consent Form  
 

China OLIMPICS Trial – Study Protocol                    Version 10.0                9 October 2018 
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Patient Details  
Initials  ……..................................................  
Date of Birth ..................................................  
Hospital No.....................................................  
 
Health professional statement 
I have explained the purpose of clinical photography/recordings to the patient and 
how the images will be used.  
 
 
Patient information leaflet has been given.  
 
 
I am a health professional requesting clinical photography and video recording. 
 
 
I will ensure that the appropriate video images are taken in a manner as to ensure 
that the patient cannot be identified. 
 
 
 
Signature of health professional...................................................  
Print Name .............................................  
Job Title ..................................................  
Contact details.......................................            Date.......... / ............. / ...........  
Patient statement (please circle your answer) I agree to have clinical video 
recordings done. The request for these has been explained to me and I fully 
understand what it entails. 
                                              Yes                       No 
Signature of patient  .............................................. Date ........./......../........ 
 
Statement of Independent Witness / Interpreter  
I have interpreted the above information to the patient to the best of my 
ability and in a way which I believe she or he can understand. 
Interpreter’s signature ..................................Name......................................Date 
......../......./....... 
References 
 

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