- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04334486
The Effects of Video Game Warm-up on EyeSi Surgical Simulator Performance
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Galveston, Texas, United States, 77555-1106
- University of Texas Medical Branch, Ophthalmology Clinical Research Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- UTMB Medical student volunteers who respond to email invitation to participate
- 18-40 years of age inclusive
Exclusion Criteria:
- Prior experience with EyeSi surgical simulator
- Not a UTMB Medical Student
- Not between 18-40 years of age inclusive
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Video Game Trained
Subjects will participate in video gaming for 10 minutes prior to Eyesi simulator test of surgical skills.
|
10 minutes of participation in Super Smash Brothers Melee prior to Eyesi Surgical Simulator evaluation of skills.
|
No Intervention: No Video Game Training
No video gaming will occur for warm up to Eyesi simulator test of surgical skills
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Video Game training effect on Eyesi Surgical Simulator Scores
Time Frame: 30 minutes
|
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.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training effect of manual dexterity activities on Eyesi Surgical Simulator Scores as reported in questionnaire.
Time Frame: 30 minutes
|
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.
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Praveena Gupta, M.D., University of Texas
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- Thomsen AS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-21. doi: 10.1111/aos.12691. Epub 2015 Feb 26.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-0110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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