CataractNCT03458442
China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial
A study testing Simulation-based surgical training and Standard surgical training in people with Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective, investigator-masked randomised controlled education-intervention trial of intense simulation-based surgical education plus conventional training versus a current six-week standard training course. Read more about this study
- Who is it for?
- Ages 0 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- Simulation-based surgical training and Standard surgical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2018to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgeon Inclusion Criteria:
- <20 complete SICS cases performed lifetime
- Completed ophthalmic training or in residency training with license to perform surgery
- Will have opportunity to carry out independent SICS surgery after training
- Patient Enrolment Criteria:
- Cataract in one or both eyes felt to be visually significant in the opinion of the operating ophthalmologist.
Who cannot join
- Surgeon Exclusion Criteria:
- Already capable of performing independent intra-ocular surgery of any kind
- No opportunity to perform cataract surgery after training.
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study
This is a prospective, investigator-masked randomised controlled education-intervention trial of intense simulation-based surgical education plus conventional training versus a current six-week standard training course. The aim is to investigate whether the addition of simulation-based surgical education to standard training improves competence and surgical outcomes. All participants in the study will receive the educational intervention of the six-week Orbis-COS course. The intervention groups will receive this training and an additional element of learning and sustained deliberate practice using model eyes and simulation.
Read the detailed description
Project Description:
The leading cause of blindness in China and the world 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, such as India (6500) and Vietnam (2250). An important reason is the unavailability of trained surgeons: though China has over 36,000 ophthalmologists, only a third are capable of performing independent cataract surgery. This shortfall is due in large part to lack of hands-on training opportunities. 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. The problem persists after formal training is completed: <5% of cataract surgeries are 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. The investigators now propose to carry out a randomized trial comparing training using these model eyes with traditional techniques, to study the impact on quality of surgery (assessed by masked grading of videos using the ICO OSCAR system), visual acuity and cost-utility outcomes.
The investigators research will reduce expenses by piggybacking on an on-going collaborative program between Orbis International, the Chinese MOH, Chinese National Blindness Prevention Committee and Tongren Hosptal (one of China's largest and best-respected eye hospitals), which will train 120 rural cataract surgeons at 60 county hospitals in 6 provinces. The study's 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.
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 Ministry of Health, while improving the lives of Chinese people dwelling in low-resource areas.
- Conditions
- Cataract
- Being tested
- Simulation-based surgical training, Standard surgical training
- Keywords
- education, developing country, developing countries, low-and middle-income country, low-and middle-income countries, surgical training, blindness, china, simulation, model
- Medical subject headings
- Cataract, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based surgical trainingOther
Those in the intervention group will be introduced to a variety of simulation-based surgical training techniques. Specifically, this will involve breaking down the SICS cataract surgery procedure into stages, and practicing each stage repeatedly using simulation. This sustained deliberate practice will be integrated into the six-week course, as an enhancement to the course, and not as a replacement of any part of the educational content. Within the last three weeks of the course, 'intervention' arm participants will be introduced to the artificial eyes, the Simulation-OSSCAR rubric, and be provided with ongoing feedback.
All participants in both intervention and control arms will undertake the six-week Orbis-COS training course.
Standard surgical trainingOther
Standard surgical training (without bespoke training scheme using simulation and model eye). All participants in both intervention and control arms will undertake the existing six-week Orbis-COS training course, which includes 2-4 weeks of didactic lectures, surgical observation, and wet lab training 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 to mentor the trainee through a minimum of 30 assisted surgeries and 50 independent surgeries under supervision.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Standard surgical training + simulation-based surgical training Receives: Other: Simulation-based surgical training; Other: Standard surgical training |
| Control Arm | Active comparator | Standard surgical training Receives: Other: Standard surgical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Skill - ICO OSCAR Score
Mean video grade of first 10 successive supervised or assisted SICS cases (with patient consent) for each trainee surgeon, using ICO-OSCAR. Two approaches to determine mean video grade will be employed to account for variation in the number of surgical steps performed by trainees.
Both approaches are equally significant for determining main outcome, differing solely in number of steps graded.
- Mean video grade across all surgical steps of first 10 supervised SICS cases for each trainee, using ICO-OSCAR. This approach assigns a score 0 for steps not performed.
- Mean video grade across all trainee-completed steps of first 10 supervised SICS cases for each trainee, using ICO-OSCAR. This approach takes into consideration mentors' teaching styles.
The graders are masked to surgeon/patient identity, using a file-sharing platform to transfer videos to graders and collate grading information. These are the first 10/30 cases completed under STEER trainer supervision.
Measured: First 10 successive independent surgeries after training--expected within 6 months after completion of training
Secondary outcomes (3)
Post-operative Presenting Visual Acuity
Mean presenting logMAR visual acuity, on post-operative day #1 of 10 successive cases per surgeon (measured using the BOOST [Better Operative Outcome Software Tool] application.
Measured: Post-operative day #1
Post-operative Improvement in Visual Acuity
Mean improvement in lines of visual acuity, on post-operative day #1 of 10 successive cases per surgeon (measured using the BOOST [Better Operative Outcome Software Tool] application.
Measured: Post-operative day #1
Cost per trainee
Cost per trainee in each wing
Measured: After conclusion of study activity--calculated up to 1 month after data from final surgery collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start9 May 2018
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Congdon Nathan, Sun Yat-sen University
- Investigators
- Nathan Congdon, MD, MPH, Principal investigator, Zongshan Ophthalmic CenterWilliam Dean, FRCO MBChB, Principal investigator, London School of Hygiene and Tropical MedicineNingli Wang, Principal investigator, Shanghai Tong Ren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458442
- Sponsor's protocol ID
- China OLIMPICS* Trial
- Status last verified
- Apr 2019
- First submitted
- 7 Oct 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murthy G, Gupta SK, John N, Vashist P. Current status of cataract blindness and Vision 2020: the right to sight initiative in India. Indian J Ophthalmol. 2008 Nov-Dec;56(6):489-94. doi: 10.4103/0301-4738.42774.
PubMed 18974520Young AL, Jhanji V, Liang Y, Congdon N, Chow S, Wang F, Zhang X, Man X, Yang M, Lin Z, Yuen HG, Lam DS. A survey of perceived training differences between ophthalmology residents in Hong Kong and China. BMC Med Educ. 2015 Sep 28;15:158. doi: 10.1186/s12909-015-0440-0.
PubMed 26415932Resnikoff S, Felch W, Gauthier TM, Spivey B. The number of ophthalmologists in practice and training worldwide: a growing gap despite more than 200,000 practitioners. Br J Ophthalmol. 2012 Jun;96(6):783-7. doi: 10.1136/bjophthalmol-2011-301378. Epub 2012 Mar 26.
PubMed 22452836Golnik C, Beaver H, Gauba V, Lee AG, Mayorga E, Palis G, Saleh GM. Development of a new valid, reliable, and internationally applicable assessment tool of residents' competence in ophthalmic surgery (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2013 Sep;111:24-33.
PubMed 24072944
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study
- ClinicalTrials.gov ID
- NCT03458442
- Acronym / sponsor ID
- China OLIMPICS* Trial
- Conditions
- Cataract
- Keywords
- education, developing country, developing countries, low-and middle-income country, low-and middle-income countries, surgical training, blindness, china
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, investigator-masked randomised controlled education-intervention trial of intense simulation-based surgical education plus conventional training versus a current six-week standard training course. The aim is to investigate whether the addition of simulation-based surgical education to standard training improves competence and surgical outcomes. All participants in the study will receive the educational intervention of the six-week Orbis-COS course. The intervention groups will receive this training and an additional element of learning and sustained deliberate practice using model eyes and simulation.
Detailed description
Project Description:
The leading cause of blindness in China and the world 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, such as India (6500) and Vietnam (2250). An important reason is the unavailability of trained surgeons: though China has over 36,000 ophthalmologists, only a third are capable of performing independent cataract surgery. This shortfall is due in large part to lack of hands-on training opportunities. 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. The problem persists after formal training is completed: <5% of cataract surgeries are 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. The investigators now propose to carry out a randomized trial comparing training using these model eyes with traditional techniques, to study the impact on quality of surgery (assessed by masked grading of videos using the ICO OSCAR system), visual acuity and cost-utility outcomes.
The investigators research will reduce expenses by piggybacking on an on-going collaborative program between Orbis International, the Chinese MOH, Chinese National Blindness Prevention Committee and Tongren Hosptal (one of China's largest and best-respected eye hospitals), which will train 120 rural cataract surgeons at 60 county hospitals in 6 provinces. The study's 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.
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 Ministry of Health, while improving the lives of Chinese people dwelling in low-resource areas.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Simulation-based surgical training, Other: Standard surgical trainingStandard surgical training + simulation-based surgical training |
| Control Arm | Active comparator | Other: Standard surgical trainingStandard surgical training |
Who may qualify
- Ages
- 0 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Surgeon Inclusion Criteria:
- Patient Enrolment Criteria:
Key exclusion criteria (7 listed)
- Surgeon Exclusion Criteria:
- Patient Exclusion Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based surgical trainingThose in the intervention group will be introduced to a variety of simulation-based surgical training techniques. Specifically, this will involve breaking down the SICS cataract surgery procedure into stages, and practicing each stage repeatedly using simulation. This sustained deliberate practice will be integrated into the six-week course, as an enhancement to the course, and not as a replacement of any part of the educational content. Within the last three weeks of the course, 'intervention' arm participants will be introduced to the artificial eyes, the Simulation-OSSCAR rubric, and be provided with ongoing feedback. All participants in both intervention and control arms will undertake the six-week Orbis-COS training course. | Other | Intervention Arm |
| Standard surgical trainingStandard surgical training (without bespoke training scheme using simulation and model eye). All participants in both intervention and control arms will undertake the existing six-week Orbis-COS training course, which includes 2-4 weeks of didactic lectures, surgical observation, and wet lab training 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 to mentor the trainee through a minimum of 30 assisted surgeries and 50 independent surgeries under supervision. | Other | Control Arm, Intervention Arm |
Primary outcome
Surgical Skill - ICO OSCAR Score
Time frame: First 10 successive independent surgeries after training--expected within 6 months after completion of training
Mean video grade of first 10 successive supervised or assisted SICS cases (with patient consent) for each trainee surgeon, using ICO-OSCAR. Two approaches to determine mean video grade will be employed to account for variation in the number of surgical steps performed by trainees. Both approaches are equally significant for determining main outcome, differing solely in number of steps graded. * Mean video grade across all surgical steps of first 10 supervised SICS cases for each trainee, using ICO-OSCAR. This approach assigns a score 0 for steps not performed. * Mean video grade across all trainee-completed steps of first 10 supervised SICS cases for each trainee, using ICO-OSCAR. This approach takes into consideration mentors' teaching styles. The graders are masked to surgeon/patient identity, using a file-sharing platform to transfer videos to graders and collate grading information. These are the first 10/30 cases completed under STEER trainer supervision.
3 secondary outcomes
Post-operative Presenting Visual Acuity
Time frame: Post-operative day #1
Post-operative Improvement in Visual Acuity
Time frame: Post-operative day #1
Cost per trainee
Time frame: After conclusion of study activity--calculated up to 1 month after data from final surgery collected
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 18974520Murthy G, Gupta SK, John N, Vashist P. Current status of cataract blindness and Vision 2020: the right to sight initiative in India. Indian J Ophthalmol. 2008 Nov-Dec;56(6):489-94. doi: 10.4103/0301-4738.42774.
- Background: PubMed 26415932Young AL, Jhanji V, Liang Y, Congdon N, Chow S, Wang F, Zhang X, Man X, Yang M, Lin Z, Yuen HG, Lam DS. A survey of perceived training differences between ophthalmology residents in Hong Kong and China. BMC Med Educ. 2015 Sep 28;15:158. doi: 10.1186/s12909-015-0440-0.
- Background: PubMed 22452836Resnikoff S, Felch W, Gauthier TM, Spivey B. The number of ophthalmologists in practice and training worldwide: a growing gap despite more than 200,000 practitioners. Br J Ophthalmol. 2012 Jun;96(6):783-7. doi: 10.1136/bjophthalmol-2011-301378. Epub 2012 Mar 26.
- Background: PubMed 24072944Golnik C, Beaver H, Gauba V, Lee AG, Mayorga E, Palis G, Saleh GM. Development of a new valid, reliable, and internationally applicable assessment tool of residents' competence in ophthalmic surgery (an American Ophthalmological Society thesis). Trans Am Ophthalmol Soc. 2013 Sep;111:24-33.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Congdon, MD, MPH principal investigator
Zongshan Ophthalmic Center
William Dean, FRCO MBChB principal investigator
London School of Hygiene and Tropical Medicine
Ningli Wang principal investigator
Shanghai Tong Ren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based surgical training and Standard surgical training in people with Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Skill - ICO OSCAR Score (time frame: First 10 successive independent surgeries after training--expected within 6 months after completion of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458442, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.