Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04908072 |
| Other study ID # |
FVR - 100177 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 23, 2021 |
| Est. completion date |
July 29, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
Orbis |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
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
- Age
- Sex
- Year of training
- Training Institution
- Number of MSICS surgeries performed as primary surgeon
- Number of MSICS surgeries assisted in or performed in part
- Total number of other ophthalmic surgeries performed (disaggregated by type)
Attending Consultants (experts)
- Sex
- Training institution
- Number of MSICS surgeries performed as primary surgeon
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)
- Complete and record three full MSICS cases using the Philips MSICS model eye and
following the steps of the OSSCAR (Appendix 4).
- Upload the 3 recorded simulated surgical procedures to the Cybersight platform
The Orbis-FVR Virtual Reality MSICS simulator has 19 steps in total. Currently, 10 steps are
animated and 9 are interactive, as follows:
1. Patient Preparation - Animated Step
2. Conjunctival Peritomy - Animated Step
3. Paracentesis - Animated Step
4. Formation of the AC - Animated Step
5. Anterior Chamber Maintainer - Animated Step
6. Marking the Scleral Incision - Interactive Step
7. Scleral Incision - Interaction Step
8. Sclerocorneal tunnel - Interactive Step
9. AC Entry - Interactive Step
10. CCC - Interactive Step
11. Hydrodissection - Animated Step
12. Mobilization of the nucleus - Interactive Step
13. Releasing the nucleus - Animated Step
14. Nucleus removal - Interactive Step
15. Cortex removal - Animated Step
16. IOL insertion - Interactive Step
17. IOL Dialling and Implantation - Interactive Step
18. Inspection of the wound - Animated Step
19. Closure of the wound - Animated Step
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:
- Narrated demonstration video of specific VR step(s)
- PowerPoint presentations
- Instrument use demonstrations
Live mentorship will be delivered in two ways:
- Local mentor who provides in-person mentorship
- International mentor from technical advisory group provides live tele-mentorship
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.
Course delivery
Each day:
Local mentor will facilitate introductions in each morning session. This will cover:
- An overview of the day's training plan
- Outlining the learning objectives for the day's training plan
- Introduction of the content covered in the day's training plan Local mentor will also
facilitate discussion and answer questions on autonomous content viewed in the morning
and midday sessions Local mentor will provide periodic check ins throughout the day's
session International mentor will provide tele-mentorship during the afternoon sessions.
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:
- Confirmation of three video uploads pre-intervention
- Simulator use and assessment logs
- Attendance records taken per daily session
- Confirmation of three video uploads post-intervention
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.
- Trainees, meeting the inclusion criteria, not being available for enrolment (due to
examinations, closure of training institutions, personal reasons).
- Connectivity issues undermining access to the VR software, orientation and training
- New technology: user comfortability with engaging in new technology
- Civil unrest (including national elections).
- Customs delays in the import of equipment or consumables.
There are expected limitations to this study:
• Some of the study locations might have opportunities for alternative cataract surgical
training, including ECCE or phacoemulsification.
