Global Learning: an Orbis Virtual-platform Evaluation Study (GLOVES)
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|ClinicalTrials.gov Identifier: NCT04908072|
Recruitment Status : Completed
First Posted : June 1, 2021
Last Update Posted : August 4, 2022
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Education||Device: Orbis-FundamentalVR MSICS Simulator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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, the 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 using model eyes (main outcome).|
|Masking:||Double (Investigator, Outcomes Assessor)|
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.
|Official Title:||Validity and Effectiveness of a Virtual Reality Simulator for Manual Small Incision Cataract Surgery: The Orbis-FundamentalVR MSICS Simulator.|
|Actual Study Start Date :||July 23, 2021|
|Actual Primary Completion Date :||July 29, 2022|
|Actual Study Completion Date :||July 29, 2022|
Active Comparator: Virtual Reality Training
Will participate in an Intensive virtual reality (R) cataract simulation course that includes a five day instructor led VR course using the Orbis-FundamentalVR cataract surgical simulator, in addition to standard resident training at the training facility.
Device: Orbis-FundamentalVR MSICS Simulator
Cataract surgery training device, using virtual reality software combined with existing gaming technology for simulated surgery
No Intervention: Traditional Training
Will receive standard resident training at the training facility.
- Mean specific simulated surgical competency assessment score at one month [ Time Frame: up to 6 months ]mean specific simulated surgical competency assessment score at one-month post-training intervention between groups (assessed using Sim-OSSCAR).
- Step-specific analysis [ Time Frame: up to 6 months ]Mean differences in Sim-OSSCAR score for the seven interactive steps assessed (incision, tunnel, AC entry, CCC, mobilization, removal and IOL). Total possible score 14.
- Self-reported confidence ratings [ Time Frame: up to 6 months ](10-point Likert scale) in MSICS skills, and ophthalmic surgical skills
- Novice and expert Orbis-FundamentalVR Simulator generated assessment scores ***As above for #2*** [ Time Frame: up to 6 months ]Construct validity study comparing scores generated by Orbis-FVR simulator between two cohorts of novice and expert MSICS surgeons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908072
|London School of Hygiene and Tropical Medicine|
|London, United Kingdom, WC1E 7HT|
|Study Chair:||Nathan Congdon, MD, MPH||Queens University Belfast|