Validity and Effectiveness of a Virtual Reality Simulator for Manual Small Incision Cataract Surgery: The Orbis-FundamentalVR MSICS Simulator.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Orbis
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Mean specific simulated surgical competency assessment score at one month
研究概览
简要总结
Currently, surgical training is often conducted using the traditional "apprentice model", where a trainee observes a qualified surgeon and learns from him/her, and then the surgeon supervises the trainee performing surgery on a patient. The investigators believe that this conventional model has substantial limitations and drawbacks, making surgical training less efficient and less safe.
The investigators will test the hypothesis that intense virtual reality (VR) simulation-based ophthalmic surgical training improves initial acquisition of competence in key stages of manual small incision cataract surgery (MSICS). To do this, the investigators are proposing a randomized multi-country study. This mixed-method study will combine qualitative and quantitative data collection.
Orbis International partnered with FundamentalVR to create a manual small incision cataract surgical (MSICS) simulator, using virtual reality software combined with existing gaming technology. The result is a VR simulator available at a fraction of the cost of products currently on the market. This VR simulator will be the subject of this study.
All training within the 'educational intervention' of this study will be performed using simulation. There is no testing or surgical training on patients.
Study Design:
Prospective, investigator-masked education-intervention randomized controlled study of intensive virtual reality (VR) simulation-based surgical education of ophthalmologists in China, Ethiopia, India, Mongolia, Bangladesh, UK and USA.
Construct validity study of assessment scores generated by the VR simulator for novices versus experts.
Qualitative study of face validity of VR simulator, and acceptability questionnaire survey of users.
Purposes of study:
To investigate the efficacy of intensive VR simulation-based surgical education using the Orbis-FVR simulator. To examine whether it improves competence, is acceptable and has validity. To assess the construct validity of the VR simulator's assessment capacity.
详细描述
Design Summary This research program involves a prospective, investigator-masked education-intervention randomized controlled study of intensive virtual reality (VR) simulation-based surgical education of ophthalmologists in China, Ethiopia, India, Mongolia, Bangladesh, UK and USA. Participants will be randomized, and surgical competency will be assessed at baseline and 1-month between groups. Competency will be assessed at baseline, using artificial eyes. Both groups will perform three full MSICS cases using model eyes at baseline. At one-month post intervention, both groups will again perform three full MSICS surgeries using model eyes for grading by masked evaluators using an existing, validated rubric (main outcome).
The study will also assess the construct validity of assessment scores generated by the VR simulator for novices versus experts. Both novices and experts will perform three full VR cases using the simulator. The first score will be disregarded to allow for familiarization with the hardware, and the mean of the second two cases will be recorded.
There will also be a qualitative study of face validity of the VR simulator, and an acceptability questionnaire-based survey of users. An anonymous survey will be administered to experts and novices, using a Likert scale.
Study Setting This is a multi-center study. The investigators will enroll trainee ophthalmologists (doctors who have graduated from medical school and are currently undergoing ophthalmology specialist training) at 9 ophthalmology training institutions in in China, Ethiopia, India, Mongolia, Bangladesh, the UK and USA.
Collaborating institutions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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 intervention/control arm.
Recordings will be converted to an MP4 format, and coded. At CyberSight, the recording will be renamed as a randomly generated seven-digit number (e.g. 6253815). The code sheet will be generated by an independent statistician and only be known to them and the CyberSight administrator. Once assessors are notified that the video is ready for marking, this random number will be the only identifiable information available when the simulation/surgical procedure is assessed, thus completely masking the assessor to the participant's intervention/control arm and personal identity.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VR Training Efficacy
- •Inclusion Criteria:
- •Trainee ophthalmologist in collaborating institution.
- •Agree to undertake simulation procedure assessments
- •Agree to undertake and complete the intensive VR simulation training course.
- •Performed 0 MSICS as primary surgeon and assisted or part-performed less than 10 MSICS cases
排除标准
- •Trainee who performed 1 or more MSICS cataract surgeries as primary surgeon and assisted or part-performed 10 or more
- •Construct Validity
- •Inclusion Criteria
- •The first cohort is novice MSICS surgeons having performed 0 MSICS procedures as primary surgeon and assisted in less than
- •The second cohort is proficient MSICS surgeons having performed a minimum of 1000 MSICS procedures
- •Exclusion Criteria
- •MSICS surgeons having performed 1 or more MSICS cataract surgeries as primary surgeon and assisted or part-performed 10 or more; or MSICS surgeons who have performed less than 1000 MSICS procedures as primary surgeon.
结局指标
主要结局
Mean specific simulated surgical competency assessment score at one month
时间窗: up to 6 months
mean specific simulated surgical competency assessment score at one-month post-training intervention between groups (assessed using Sim-OSSCAR).
次要结局
- Step-specific analysis(up to 6 months)
- Self-reported confidence ratings(up to 6 months)