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

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ClinicalTrials.gov Identifier: NCT04450420
Recruitment Status : Completed
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
HelpMeSee Inc.

Study Description
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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
Cataract Other: Simulation based curriculum Other: Standard training Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 28, 2018
Actual Primary Completion Date : August 16, 2019
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Simulation based curriculum

Three phases:

  1. 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.
  2. Instructor led teaching - didactic training, lab activities to gain familiarity with instruments, simulator based training through deliberate practice, and debriefing with instructor.
  3. 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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450420


Locations
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United States, New York
HelpMeSee Inc.
New York, New York, United States, 10018
Sponsors and Collaborators
HelpMeSee Inc.
More Information
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Responsible Party: HelpMeSee Inc.
ClinicalTrials.gov Identifier: NCT04450420    
Other Study ID Numbers: TCCPASTE
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HelpMeSee Inc.:
cataract
MSICS
manual small incision cataract surgery
surgical simulation
simulation
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases