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
|First Submitted Date ICMJE||May 13, 2021|
|First Posted Date ICMJE||June 1, 2021|
|Last Update Posted Date||August 4, 2022|
|Actual Study Start Date ICMJE||July 23, 2021|
|Actual Primary Completion Date||July 29, 2022 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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).
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures
||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.
|Original Other Pre-specified Outcome Measures||Same as current|
|Brief Title ICMJE||Global Learning: an Orbis Virtual-platform Evaluation Study|
|Official Title ICMJE||Validity and Effectiveness of a Virtual Reality Simulator for Manual Small Incision Cataract Surgery: The Orbis-FundamentalVR MSICS Simulator.|
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.
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.
London School of Hygiene and Tropical Medicine, UK Chittagong Eye Infirmary and Training Complex, Chittagong, Bangladesh Addis Ababa University, department of Ophthalmology, Menelik II Hospital, Addis Ababa, Ethiopia University of Gondar, Gondar, Ethiopia Dr. Shroff's Charity Eye Hospital (SCEH), New Delhi, India H.V. Desai Eye Hospital, Pune, India The First Central Hospital,, Ulaanbaatar, Mongolia Shenyang He Eye Specialist Hospital, China. Emory Eye Center, Atlanta, GA USA
Study Duration The training will be conducted during 2021, and will last 6 months.
Study Participants Current trainees enrolled between January and December of 2021 in all 9 training institutions will be selected according to the inclusion and exclusion criteria.
Informed Consent Potential participant trainees will be informed of the training opportunity and the study. Heads of Department will be involved in the process. Trainee participants will be informed in detail about the nature of the education-intervention study, that the training offered provides no official qualification and will not be recorded in their annual clinical training evaluation. All surgeons participating will be free to leave the study at any time.
Withdrawal Criteria Trainee participants are free to leave the study at any time. If this is the case for any participant, no effort will be made to recover any costs incurred. Data collected up to the point of withdrawal of consent will have been pseudo-anonymized and securely stored and will still be held and included in data analysis
Baseline Data Resident Trainees
Attending Consultants (experts)
Randomisation Sequence generation The randomization sequences will be computer generated and administered centrally by a statistician based at the London School of Hygiene and Tropical Medicine, who is independent of all other aspects of the trial. The investigators will use block randomization (block size 2 or 4), with a separate sequence for each of the ten recruitment sites, to ensure balance. The statistician will generate the code / sequence (as a block of 2 or 4).
Allocation Concealment The statistician will not have access to information about subsequent allocation, and the individual potential participants. The PI, co-investigators, and participants will have no prior access to the random sequence.
Randomization Implementation Trainees within the same institution, who have met the appropriate inclusion and exclusion (as detailed previously), will be eligible for randomization to the 'intervention' or 'control' arm. Each group of four trainee participants will be agreed by the Head of Training Program or Department.
For example (Blocks will be in groups of 4, 6 or 8 depending on the institution and the number of residents that meet the inclusion criteria):
A block of four potential participants is identified at Chittagong Eye Institute Training Center (CEITC), Bangladesh. Cards with the allocation or a block of four (two intervention and two control) will be printed and placed in sealed opaque envelopes. Physically, in Bangladesh, a block of four identical envelopes (e.g. block number 11) will be selected. Participants will be invited by the Head of Department to pick one of the four envelopes. In this example, CEITC randomization block 11 allocation might be:
IRO1101 Intervention IRO1102 Control IRO1103 Control IRO1104 Intervention
Training Intervention - Orbis-FVR Training Program
Pre-Learning (one month in advance)
• Surgical video review ***Stipulated number or total time spent?***
Pre-Course Assignment (one week in advance)
The Orbis-FVR Virtual Reality MSICS simulator has 19 steps in total. Currently, 10 steps are animated and 9 are interactive, as follows:
Course Overview Participants must attend and successfully complete all sessions. All simulator tasks are to be completed in sequential order, in line with the course outline. A required score of 85 points for each interactive step must be reached three times in a row to advance to the next step in the course.
For each step within the simulation the following is recorded:
Step Time - The total time spent on a step including ALL attempts. Pass / Fail - The interpreted pass or fail result of the last attempt of the step.
Step score - Each step is scored between 0 and 100 points, based on user performance in completing the surgical objective, taking into account any adverse events.
Adverse events - For each step, if triggered, all of the adverse events are recorded.
Number of attempts - The number of attempts (including resets) of the step.
Course Content Each course will combine autonomous learning and live mentorship.
Autonomous learning will consist of a series of 15-minute video presentations, which include:
Live mentorship will be delivered in two ways:
Content hosting All content will be hosted on the Orbis Cybersight Learning Management System platform. Data will be randomized and anonymized by the Cybersight Program manager, who will not be involved in any other aspect of the research initiative.
Local mentor will facilitate introductions in each morning session. This will cover:
Trainees will do self-practice for the remainder of the afternoon session
The MSICS simulator has a built in surgical assessment per step. Each interactive step has a possible score between 0 and 100. A score of 85 indicates "passing." Each trainee will complete each interactive step on the VR simulator a minimum of 5 times with a reliability gate (3) and minimum score of 85. Reliability gate of 3 was chosen based on similar interventions using like VR cataract simulators. Each trainee will complete at least 5 full cases on the VR simulator with a reliability gate (3) and minimum score of 85
Attendance to be recorded as follows:
Oversight and validation of the above will be done by the local mentor, as well as study personnel. The simulator itself will log that participants completed each step, with a detail of their performance, length of time spent, adverse events, score and final mark of pass/fail.
Risks and Limitations
There are no clinical risks within this study, as all the intervention training uses simulation. No patients are involved in any of the training. Patients are involved only as part of fully supervised, standardized, regulated and accredited post-graduate clinical and surgical training within the collaborating training institutions, all of which falls outside the study.
There are a number of broad risks in conducting this study.
There are expected limitations to this study:
• Some of the study locations might have opportunities for alternative cataract surgical training, including ECCE or phacoemulsification.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
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)
Primary Purpose: Other
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.
|Condition ICMJE||Surgical Education|
|Intervention ICMJE||Device: Orbis-FundamentalVR MSICS Simulator
Cataract surgery training device, using virtual reality software combined with existing gaming technology for simulated surgery
|Study Arms ICMJE||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date ICMJE||July 29, 2022|
|Actual Primary Completion Date||July 29, 2022 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
VR Training Efficacy
• Trainee who performed 1 or more MSICS cataract surgeries as primary surgeon and assisted or part-performed 10 or more
• 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.
|Ages ICMJE||Child, Adult, Older Adult|
|Accepts Healthy Volunteers ICMJE||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United Kingdom|
|Removed Location Countries|
|NCT Number ICMJE||NCT04908072|
|Other Study ID Numbers ICMJE||FVR - 100177|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Current Responsible Party||Orbis|
|Original Responsible Party||Same as current|
|Current Study Sponsor ICMJE||Orbis|
|Original Study Sponsor ICMJE||Same as current|
|Verification Date||August 2022|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP