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Completed

NCT Number: NCT04450420

Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

HelpMeSee Inc.

New York, 10018, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Simulation based curriculum

Other

See arm/group description

Standard Training

Other

See arm/group description

Primary outcomes

  1. Total surgical errors

    Time frame: 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 outcomes

  1. Major surgical errors

    Time frame: 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

    Time frame: 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

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  4. Surgical product/outcome assessment: tunnel dissection

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  5. Surgical product/outcome assessment: paracentesis

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  6. Surgical product/outcome assessment: viscoelastic injection/exchange

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  7. Surgical product/outcome assessment: keratome entry and extensions

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  8. Overall technical skill for tunnel construction

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  9. Technical skill: scleral groove

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  10. Technical skill: tunnel dissection

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  11. Technical skill: paracentesis

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  12. Technical skill: viscoelastic injection/exchange

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  13. Technical skill: keratome entry and extensions

    Time frame: 12 weeks

    Custom developed structured rating scale; video-based assessment

  14. Task-specific technical skill: scleral tunnel

    Time frame: 12 weeks

    ICO-OSCAR:SICS; video-based assessment

  15. Task-specific technical skill: corneal entry

    Time frame: 12 weeks

    ICO-OSCAR:SICS; video-based assessment

  16. Task-specific technical skill: paracentesis & viscoelastic exchange

    Time frame: 12 weeks

    ICO-OSCAR:SICS; video-based assessment

  17. Global technical skill

    Time frame: 12 weeks

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

Other outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

HelpMeSee Inc.

Other

Registry information

Acronym: TCC-PASTE

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jun 29, 2020
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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