- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03458442
China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial
China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Zhongshan Ophthalmic Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
Standard surgical training + simulation-based surgical training
|
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 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.
|
Active Comparator: Control Arm
Standard surgical training
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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. |
First 10 successive independent surgeries after training--expected within 6 months after completion of training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Presenting Visual Acuity
Time Frame: Post-operative day #1
|
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.
|
Post-operative day #1
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Post-operative Improvement in Visual Acuity
Time Frame: Post-operative day #1
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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.
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Post-operative day #1
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Cost per trainee
Time Frame: After conclusion of study activity--calculated up to 1 month after data from final surgery collected
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Cost per trainee in each wing
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After conclusion of study activity--calculated up to 1 month after data from final surgery collected
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nathan Congdon, MD, MPH, Zongshan Ophthalmic Center
- Principal Investigator: William Dean, FRCO MBChB, London School of Hygiene and Tropical Medicine
- Principal Investigator: Ningli Wang, Tongren Hospital
Publications and helpful links
General 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.
- Young 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.
- Resnikoff 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.
- Golnik 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- China OLIMPICS* Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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