NCT04334486

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

April 1, 2020

Last Update Submit

August 5, 2021

Conditions

Keywords

training effectbimanual dexteritysurgical skillsophthalmology

Outcome Measures

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.

    30 minutes

Secondary Outcomes (1)

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

    30 minutes

Study Arms (2)

Video Game Trained

EXPERIMENTAL

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

Other: Super Smash Brothers Melee (Gamecube)

No Video Game Training

NO INTERVENTION

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

Interventions

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

Video Game Trained

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch, Ophthalmology Clinical Research Center

Galveston, Texas, 77555-1106, United States

Location

Related Publications (11)

  • 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.

    PMID: 21516035BACKGROUND
  • 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.

    PMID: 23796766BACKGROUND
  • 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.

    PMID: 23007233BACKGROUND
  • 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.

    PMID: 12368674BACKGROUND
  • 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.

    PMID: 25722080BACKGROUND
  • 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.

    PMID: 24612448BACKGROUND
  • 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.

    PMID: 19444047BACKGROUND
  • 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.

    PMID: 28017423BACKGROUND
  • 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.

    PMID: 24160383BACKGROUND
  • 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.

    PMID: 23111035BACKGROUND
  • 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.

    PMID: 23760943BACKGROUND

Study Officials

  • Praveena Gupta, M.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-blinded parallel examination of training or non-training effect of video game participation prior to Eyesi surgical simulator evaluation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 6, 2020

Study Start

September 17, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

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.

Locations