TCC-PASTE: Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Sponsor
HelpMeSee Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT04450420
Collaborator
(none)
24
1
2
21.1
1.1

Study Details

Study Description

Brief Summary

TCC-PASTE is a randomised controlled trial comparing a simulation based training curriculum with standard training for ophthalmology residents learning to perform tunnel construction in manual small incision cataract surgery. After obtaining informed consent, participating trainees will be randomly assigned to learn to perform tunnel construction either through the simulation based curriculum or through the standard curriculum at their institute. Trainees assigned to simulation will learn through studying an eBook, participating in training sessions supported by repeated practice on a virtual reality simulator, and supervised training in live surgery to facilitate transfer of skill acquired in simulation to the operating room. To determine the effect of simulation based training, we will assess the number of errors trainees perform in the initial part of their intraoperative learning curve.

Condition or Disease Intervention/Treatment Phase
  • Other: Simulation based curriculum
  • Other: Standard training
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Expert raters assessing outcomes by watching videos of surgery were masked to the identity of the participating surgeon, their institutional affiliation, and the sequence in which they performed procedures in the trial.
Primary Purpose:
Other
Official Title:
Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
Actual Study Start Date :
Aug 28, 2018
Actual Primary Completion Date :
Aug 16, 2019
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Simulation based curriculum

Three phases: Self-study of an eBook - Participating trainees will be required to learn material pertaining to tunnel construction and general surgical principles during SICS from an eBook that has been developed by HelpMeSee. Instructor led teaching - didactic training, lab activities to gain familiarity with instruments, simulator based training through deliberate practice, and debriefing with instructor. Instructor supervised performance of surgery on patients in the operating room.

Other: Simulation based curriculum
See arm/group description

Active Comparator: Standard training

Current standard curriculum for resident training.

Other: Standard training
See arm/group description

Outcome Measures

Primary Outcome Measures

  1. Total surgical errors [12 weeks]

    Incidence of pre-specified errors during tunnel construction through video-based assessment: uveal prolapse (UP), buttonhole incision (BI), premature entry (PE), Descemet's detachment (DD), laceration of upper wall (UL), laceration of lateral walls of tunnel (LL), corneal endothelial touch (ET), contact with iris, (IC) and contact with the lens (LC).

Secondary Outcome Measures

  1. Major surgical errors [12 weeks]

    Incidence of pre-specified errors during tunnel construction through video-based assessment: uveal prolapse (UP), buttonhole incision (BI), premature entry (PE), Descemet's detachment (DD), laceration of upper wall (UL), laceration of lateral walls of tunnel (LL).

  2. Minor surgical errors [12 weeks]

    Incidence of pre-specified errors during tunnel construction through video-based assessment: corneal endothelial touch (ET), contact with iris, (IC) and contact with the lens (LC).

  3. Surgical product/outcome assessment: scleral groove [12 weeks]

    Custom developed structured rating scale; video-based assessment

  4. Surgical product/outcome assessment: tunnel dissection [12 weeks]

    Custom developed structured rating scale; video-based assessment

  5. Surgical product/outcome assessment: paracentesis [12 weeks]

    Custom developed structured rating scale; video-based assessment

  6. Surgical product/outcome assessment: viscoelastic injection/exchange [12 weeks]

    Custom developed structured rating scale; video-based assessment

  7. Surgical product/outcome assessment: keratome entry and extensions [12 weeks]

    Custom developed structured rating scale; video-based assessment

  8. Overall technical skill for tunnel construction [12 weeks]

    Custom developed structured rating scale; video-based assessment

  9. Technical skill: scleral groove [12 weeks]

    Custom developed structured rating scale; video-based assessment

  10. Technical skill: tunnel dissection [12 weeks]

    Custom developed structured rating scale; video-based assessment

  11. Technical skill: paracentesis [12 weeks]

    Custom developed structured rating scale; video-based assessment

  12. Technical skill: viscoelastic injection/exchange [12 weeks]

    Custom developed structured rating scale; video-based assessment

  13. Technical skill: keratome entry and extensions [12 weeks]

    Custom developed structured rating scale; video-based assessment

  14. Task-specific technical skill: scleral tunnel [12 weeks]

    ICO-OSCAR:SICS; video-based assessment

  15. Task-specific technical skill: corneal entry [12 weeks]

    ICO-OSCAR:SICS; video-based assessment

  16. Task-specific technical skill: paracentesis & viscoelastic exchange [12 weeks]

    ICO-OSCAR:SICS; video-based assessment

  17. Global technical skill [12 weeks]

    Global indices in ICO-OSCAR:SICS; video-based assessment

Other Outcome Measures

  1. Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error [12 weeks]

    Any physical intervention or assistance by supervising surgeon is counted as an additional error

  2. Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error [12 weeks]

    Any physical intervention or assistance by supervising surgeon is counted as an additional error

  3. Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error [12 weeks]

    Any physical intervention or assistance by supervising surgeon is counted as an additional error

  4. Incidence of any physical intervention or assistance by supervising surgeon [12 weeks]

    Each instance of physical intervention or assistance by supervising surgeon is counted as one event.

  5. Incidence of complete intervention or assistance by supervising surgeon [12 weeks]

    Each instance of ake-over by supervising surgeon for the specific activity or rest of task is counted as one event.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Enrolled in a training program at a partner institute;

  • No or minimal prior experience with MSICS (trainees within the first 2-3 months of matriculation, or having performed fewer than 20 procedures as the main surgeon but no more than 5 MSICS procedures within 6 months preceding participation in TCC-PASTE);

  • Provide informed consent to participate in the study;

  • Able to participate in routine patient care activities, as required by the partner institute, without the need to take overnight call for the duration corresponding to the simulation training phase.

Exclusion Criteria:
  • Performed scleral tunnel construction as the main surgeon in 20 or more procedures;

  • Prior experience with the HelpMeSee simulator or participation in the HelpMeSee simulation training curriculum.

  • Required to take overnight call for the duration corresponding to simulation training phase.

Contacts and Locations

Locations

Site City State Country Postal Code
1 HelpMeSee Inc. New York New York United States 10018

Sponsors and Collaborators

  • HelpMeSee Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
HelpMeSee Inc.
ClinicalTrials.gov Identifier:
NCT04450420
Other Study ID Numbers:
  • TCCPASTE
First Posted:
Jun 29, 2020
Last Update Posted:
Jun 29, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by HelpMeSee Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 29, 2020