China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03458442 |
Recruitment Status :
Completed
First Posted : March 8, 2018
Last Update Posted : March 19, 2021
|
Tracking Information | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | October 7, 2017 | |||||||||
First Posted Date ICMJE | March 8, 2018 | |||||||||
Last Update Posted Date | March 19, 2021 | |||||||||
Actual Study Start Date ICMJE | May 9, 2018 | |||||||||
Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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.
|
|||||||||
Original Primary Outcome Measures ICMJE |
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 across all steps on first 10 SICS cases for each surgeon, using ICO OSCAR, with grader masked to surgeon/patient identity and using the Orbis CyberSight platform to transfer videos to graders and collate grading information.
|
|||||||||
Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
|
|||||||||
Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
Descriptive Information | ||||||||||
Brief Title ICMJE | China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial | |||||||||
Official Title ICMJE | China OLIMPICS: China Ophthalmic Learning and Improvement Initiative in Cataract Surgery Trial, an Education-Intervention Randomized Control Study | |||||||||
Brief 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. 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 Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Not Applicable | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Health Services Research |
|||||||||
Condition ICMJE | Cataract | |||||||||
Intervention ICMJE |
|
|||||||||
Study Arms ICMJE |
|
|||||||||
Publications * |
|
|||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
32 | |||||||||
Original Estimated Enrollment ICMJE |
28 | |||||||||
Actual Study Completion Date ICMJE | February 1, 2020 | |||||||||
Actual Primary Completion Date | January 1, 2020 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
Sex/Gender ICMJE |
|
|||||||||
Ages ICMJE | 0 Years to 100 Years (Child, Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | No | |||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
Listed Location Countries ICMJE | China | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03458442 | |||||||||
Other Study ID Numbers ICMJE | China OLIMPICS* Trial | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product |
|
|||||||||
IPD Sharing Statement ICMJE |
|
|||||||||
Current Responsible Party | Congdon Nathan, Sun Yat-sen University | |||||||||
Original Responsible Party | Same as current | |||||||||
Current Study Sponsor ICMJE | Sun Yat-sen University | |||||||||
Original Study Sponsor ICMJE | Same as current | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
|
|||||||||
PRS Account | Sun Yat-sen University | |||||||||
Verification Date | April 2019 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |