CClinicalTrials.gg
CompletedNCT04334486Updated Aug 6, 2021

The Effects of Video Game Warm-up on EyeSi Surgical Simulator Performance

An interventional study of Super Smash Brothers Melee (Gamecube) in High Fidelity Simulation Training, sponsored by The University of Texas Medical Branch, Galveston. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-06.

Sponsored by The University of Texas Medical Branch, Galveston · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

This study will examine the history of video game use an activities of manual dexterity with the scored skills used in the Eyesi surgical simulator. Subjects will be asked to participate in video games or no video games prior to testing skills in Eyesi to examine training effects of video game participation and changes in manual dexterity.

Read the detailed description

A popular crossover fighting video game released in 2001 for the Nintendo Gamecube that emphasizes reflexes and dexterity to perform specific maneuvers will be used in this study as a potential dexterity trainer.

The Eyesi is a training device utilized in many ophthalmology residency training programs to improve intraocular operative skills. The EyeSi is a validated training tool that uses high-end virtual reality that can be equipped with instrumentation for cataract or vitreoretinal surgery. The device itself consists of eyepieces that replicate a surgical scope, a mannequin head where handpiece probes can be inserted and position tracked to virtually recreate a surgical environment. The simulator also has a monitor that can be used to see the surgical simulator environment. As part of the software, numerous training tasks and exercises are available programmed into the device. These exercises utilize numerous metrics such as distance traveled, tissue treatment, efficiency, instrument handing, and others to provide the user with a raw score out of 100 for each task.

Subjects will then be asked to complete a manual dexterity questionnaire including history of video game use as well as tasks demonstrating manual dexterity ability such as the ability to play a musical instrument. Participants will then be randomized to the intervention group or the control group.

The intervention group will be asked to play 10 minutes of the Gamecube game "Super Smash Brothers Melee" as their "warm-up" prior to completing the EyeSi surgical tasks of navigation, forceps, and bimanual with their scores collected and averaged across all tasks.

The control group will complete the EyeSi surgical tasks of navigation, forceps, and bimanual with their scores collected and averaged, but will not perform a "warm-up" task.

Planned statistical analysis will include an average of total scores across navigation, forceps, and bimanual tasks. Chi square analysis will then be utilized to determine any statistical significance between intervention and control groups. Simulator scores will also be associated with questionnaire responses and simple linear regression will be used for analysis.

02

Conditions studied

  • High Fidelity Simulation Training

Keywords

  • training effect
  • bimanual dexterity
  • surgical skills
  • ophthalmology
03

In context

Lead sponsor

The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • UTMB Medical student volunteers who respond to email invitation to participate
  • 18-40 years of age inclusive

Exclusion criteria

Exclusion Criteria:

  • Prior experience with EyeSi surgical simulator
  • Not a UTMB Medical Student
  • Not between 18-40 years of age inclusive
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Video Game Trained

    Subjects will participate in video gaming for 10 minutes prior to Eyesi simulator test of surgical skills.

    Other: Super Smash Brothers Melee (Gamecube)

  • No intervention
    No Video Game Training

    No video gaming will occur for warm up to Eyesi simulator test of surgical skills

Interventions

  • OtherSuper Smash Brothers Melee (Gamecube)

    10 minutes of participation in Super Smash Brothers Melee prior to Eyesi Surgical Simulator evaluation of skills.

06

What researchers measure

Primary outcomes

  1. Video Game training effect on Eyesi Surgical Simulator Scores

    Planned statistical analysis will include an average of total scores across navigation, forceps, and bimanual tasks. Chi square analysis will then be utilized to determine any statistical significance between intervention and control groups.

    Time frame: 30 minutes

Secondary outcomes

  1. Training effect of manual dexterity activities on Eyesi Surgical Simulator Scores as reported in questionnaire.

    Subjects will then be asked to complete a manual dexterity questionnaire including history of video game use as well as tasks demonstrating manual dexterity ability such as the ability to play a musical instrument. Simulator scores will be associated with questionnaire responses and simple linear regression will be used for analysis.

    Time frame: 30 minutes

07

Study locations

1 site
  • University of Texas Medical Branch, Ophthalmology Clinical Research Center
    Galveston, Texas 77555-1106, United States
08

References and documents

Publications

  • Crochet P, Aggarwal R, Dubb SS, Ziprin P, Rajaretnam N, Grantcharov T, Ericsson KA, Darzi A. Deliberate practice on a virtual reality laparoscopic simulator enhances the quality of surgical technical skills. Ann Surg. 2011 Jun;253(6):1216-22. doi: 10.1097/SLA.0b013e3182197016. PubMed 21516035 ↗
  • McCannel CA, Reed DC, Goldman DR. Ophthalmic surgery simulator training improves resident performance of capsulorhexis in the operating room. Ophthalmology. 2013 Dec;120(12):2456-2461. doi: 10.1016/j.ophtha.2013.05.003. Epub 2013 Jun 21. PubMed 23796766 ↗
  • Pokroy R, Du E, Alzaga A, Khodadadeh S, Steen D, Bachynski B, Edwards P. Impact of simulator training on resident cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2013 Mar;251(3):777-81. doi: 10.1007/s00417-012-2160-z. Epub 2012 Sep 25. PubMed 23007233 ↗
  • Seymour NE, Gallagher AG, Roman SA, O'Brien MK, Bansal VK, Andersen DK, Satava RM. Virtual reality training improves operating room performance: results of a randomized, double-blinded study. Ann Surg. 2002 Oct;236(4):458-63; discussion 463-4. doi: 10.1097/00000658-200210000-00008. PubMed 12368674 ↗
  • Thomsen ASS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-421. doi: 10.1111/aos.12691. Epub 2015 Feb 26. PubMed 25722080 ↗
  • Bergqvist J, Person A, Vestergaard A, Grauslund J. Establishment of a validated training programme on the Eyesi cataract simulator. A prospective randomized study. Acta Ophthalmol. 2014 Nov;92(7):629-34. doi: 10.1111/aos.12383. Epub 2014 Mar 11. PubMed 24612448 ↗
  • Solverson DJ, Mazzoli RA, Raymond WR, Nelson ML, Hansen EA, Torres MF, Bhandari A, Hartranft CD. Virtual reality simulation in acquiring and differentiating basic ophthalmic microsurgical skills. Simul Healthc. 2009 Summer;4(2):98-103. doi: 10.1097/SIH.0b013e318195419e. PubMed 19444047 ↗
  • Thomsen AS, Bach-Holm D, Kjaerbo H, Hojgaard-Olsen K, Subhi Y, Saleh GM, Park YS, la Cour M, Konge L. Operating Room Performance Improves after Proficiency-Based Virtual Reality Cataract Surgery Training. Ophthalmology. 2017 Apr;124(4):524-531. doi: 10.1016/j.ophtha.2016.11.015. Epub 2016 Dec 22. PubMed 28017423 ↗
  • Daly MK, Gonzalez E, Siracuse-Lee D, Legutko PA. Efficacy of surgical simulator training versus traditional wet-lab training on operating room performance of ophthalmology residents during the capsulorhexis in cataract surgery. J Cataract Refract Surg. 2013 Nov;39(11):1734-41. doi: 10.1016/j.jcrs.2013.05.044. PubMed 24160383 ↗
  • Adams BJ, Margaron F, Kaplan BJ. Comparing video games and laparoscopic simulators in the development of laparoscopic skills in surgical residents. J Surg Educ. 2012 Nov-Dec;69(6):714-7. doi: 10.1016/j.jsurg.2012.06.006. PubMed 23111035 ↗
  • Middleton KK, Hamilton T, Tsai PC, Middleton DB, Falcone JL, Hamad G. Improved nondominant hand performance on a laparoscopic virtual reality simulator after playing the Nintendo Wii. Surg Endosc. 2013 Nov;27(11):4224-31. doi: 10.1007/s00464-013-3027-z. Epub 2013 Jun 13. PubMed 23760943 ↗

Individual participant data

Plan to share: No — Data will be assigned a unique participant identification number and no personal information will be collected as part of the data set. Information from the questionnaire and study tasks will be associated with your subject identification number not any personal identifiers. Your participation or lack of participation will not be made known to any individuals outside of the study personnel with which you interface and will also be unavailable to any faculty within the UTMB Ophthalmology program to ensure that there is no risk in participation affecting future departmental relationships, evaluations or considerations.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04334486
Lead sponsor
The University of Texas Medical Branch, Galveston
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Sep 17, 2020
Primary completion
Jul 15, 2021
Completion
Jul 15, 2021
Last update
Aug 6, 2021

Study contacts

Praveena Gupta, M.D.
principal investigator · University of Texas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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