Global Learning: an Orbis Virtual-platform Evaluation Study

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

Interventions

DEVICE

Orbis-FundamentalVR MSICS Simulator

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

Sponsors & Collaborators

• Queen's University, Belfast

  collaborator OTHER

• FundamentalVR

  collaborator UNKNOWN

• Dr Shroff's Charity Eye Hospital

  collaborator UNKNOWN

• H.V. Desai Eye Hospital

  collaborator UNKNOWN

• Chittagong Eye Infirmary and Training Complex

  collaborator UNKNOWN

• Menelik II Hospital

  collaborator UNKNOWN

• University of Gondar

  collaborator OTHER

• The First Central Hospital

  collaborator UNKNOWN

• He Eye Hospital

  collaborator OTHER

• Emory Eye Center

  collaborator UNKNOWN

• Lome MSICS Teaching. Institute

  collaborator UNKNOWN

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Orbis

  lead OTHER

Principal Investigators

• Nathan Congdon, MD, MPH · Queens University Belfast

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-23

Primary Completion

2022-07-29

Completion

2022-07-29

Countries

• United Kingdom

Study Locations