Global Learning: an Orbis Virtual-platform Evaluation Study

NCT04908072 | Completed

• 1 other identifier: FVR - 100177
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Education

Keywords

Virtual reality; Simulation; Surgical Education; Cataract

Outcome Measures

Primary Outcomes (1)

• Mean specific simulated surgical competency assessment score at one month

  mean specific simulated surgical competency assessment score at one-month post-training intervention between groups (assessed using Sim-OSSCAR).

  up to 6 months

Secondary Outcomes (2)

• Step-specific analysis

  up to 6 months

• Self-reported confidence ratings

  up to 6 months

Other Outcomes (1)

• Novice and expert Orbis-FundamentalVR Simulator generated assessment scores ***As above for #2***

  up to 6 months

Study Arms (2)

Virtual Reality Training

ACTIVE COMPARATOR

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

Traditional Training

NO INTERVENTION

Will receive standard resident training at the training facility.

Interventions

Orbis-FundamentalVR MSICS Simulator DEVICE

Cataract surgery training device, using virtual reality software combined with existing gaming technology for simulated surgery

Virtual Reality Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Trainee who performed 1 or more MSICS cataract surgeries as primary surgeon and assisted or part-performed 10 or more
• Construct Validity
• The first cohort is novice MSICS surgeons having performed 0 MSICS procedures as primary surgeon and assisted in less than 10.
• The second cohort is proficient MSICS surgeons having performed a minimum of 1000 MSICS procedures
• 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.

Sponsors & Collaborators

• Orbis: lead
• Queen's University, Belfast: collaborator
• FundamentalVR: collaborator
• Dr Shroff's Charity Eye Hospital: collaborator
• H.V. Desai Eye Hospital: collaborator
• Chittagong Eye Infirmary and Training Complex: collaborator
• Menelik II Hospital: collaborator
• University of Gondar: collaborator
• The First Central Hospital: collaborator
• He Eye Hospital: collaborator
• Emory Eye Center: collaborator
• Lome MSICS Teaching. Institute: collaborator
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Nathan Congdon, MD, MPH

  Queens University Belfast

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 1, 2021
• Study Start: July 23, 2021
• Primary Completion: July 29, 2022
• Study Completion: July 29, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)