Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Study Overview
=================
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.

Official Title
-----------------
Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Other: Simulation based curriculum
* Other: Standard training


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simulation based curriculum<br>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<br>* See arm/group description<br>|
| Active Comparator: Standard training<br>Current standard curriculum for resident training. | Other: Standard training<br>* See arm/group description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total surgical errors | 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). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major surgical errors | 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). | 12 weeks | 
| Minor surgical errors | 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). | 12 weeks | 
| Surgical product/outcome assessment: scleral groove | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Surgical product/outcome assessment: tunnel dissection | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Surgical product/outcome assessment: paracentesis | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Surgical product/outcome assessment: viscoelastic injection/exchange | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Surgical product/outcome assessment: keratome entry and extensions | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Overall technical skill for tunnel construction | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Technical skill: scleral groove | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Technical skill: tunnel dissection | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Technical skill: paracentesis | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Technical skill: viscoelastic injection/exchange | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Technical skill: keratome entry and extensions | Custom developed structured rating scale; video-based assessment | 12 weeks | 
| Task-specific technical skill: scleral tunnel | ICO-OSCAR:SICS; video-based assessment | 12 weeks | 
| Task-specific technical skill: corneal entry | ICO-OSCAR:SICS; video-based assessment | 12 weeks | 
| Task-specific technical skill: paracentesis & viscoelastic exchange | ICO-OSCAR:SICS; video-based assessment | 12 weeks | 
| Global technical skill | Global indices in ICO-OSCAR:SICS; video-based assessment | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, MSICS, manual small incision cataract surgery, surgical simulation, simulation