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Global Learning: an Orbis Virtual-platform Evaluation Study (GLOVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04908072
Recruitment Status : Completed
First Posted : June 1, 2021
Last Update Posted : August 4, 2022
Sponsor:
Collaborators:
Queen's University, Belfast
FundamentalVR
Dr Shroff's Charity Eye Hospital
H.V. Desai Eye Hospital
Chittagong Eye Infirmary and Training Complex
Menelik II Hospital
University of Gondar
The First Central Hospital
He Eye Hospital
Emory Eye Center
Lome MSICS Teaching. Institute
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Orbis

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.


Condition or disease Intervention/treatment Phase
Surgical Education Device: Orbis-FundamentalVR MSICS Simulator Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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)
Masking Description:

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.

Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. Self-reported confidence ratings [ Time Frame: up to 6 months ]
    (10-point Likert scale) in MSICS skills, and ophthalmic surgical skills


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

VR Training Efficacy

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Trainee who performed 1 or more MSICS cataract surgeries as primary surgeon and assisted or part-performed 10 or more

Construct Validity

Inclusion Criteria

  • 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

Exclusion Criteria

• 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.


Information from the National Library of Medicine

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


Locations
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United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, WC1E 7HT
Sponsors and Collaborators
Orbis
Queen's University, Belfast
FundamentalVR
Dr Shroff's Charity Eye Hospital
H.V. Desai Eye Hospital
Chittagong Eye Infirmary and Training Complex
Menelik II Hospital
University of Gondar
The First Central Hospital
He Eye Hospital
Emory Eye Center
Lome MSICS Teaching. Institute
London School of Hygiene and Tropical Medicine
Investigators
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Study Chair: Nathan Congdon, MD, MPH Queens University Belfast
  Study Documents (Full-Text)

Documents provided by Orbis:
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Responsible Party: Orbis
ClinicalTrials.gov Identifier: NCT04908072    
Other Study ID Numbers: FVR - 100177
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: August 4, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Orbis:
Virtual reality
Simulation
Surgical Education
Cataract