Cataract
Conditions
Keywords
cataract, MSICS, manual small incision cataract surgery, surgical simulation, simulation
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.
Interventions
OTHERSimulation based curriculum
See arm/group description
OTHERStandard training
See arm/group description
Sponsors
HelpMeSee Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Surgical product/outcome assessment: keratome entry and extensions | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Technical skill: keratome entry and extensions | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Task-specific technical skill: scleral tunnel | 12 weeks | ICO-OSCAR:SICS; video-based assessment |
| Task-specific technical skill: corneal entry | 12 weeks | ICO-OSCAR:SICS; video-based assessment |
| Task-specific technical skill: paracentesis & viscoelastic exchange | 12 weeks | ICO-OSCAR:SICS; video-based assessment |
| Global technical skill | 12 weeks | Global indices in ICO-OSCAR:SICS; video-based assessment |
| 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). |
| 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). |
| Surgical product/outcome assessment: scleral groove | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Surgical product/outcome assessment: tunnel dissection | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Surgical product/outcome assessment: paracentesis | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Surgical product/outcome assessment: viscoelastic injection/exchange | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Overall technical skill for tunnel construction | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Technical skill: scleral groove | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Technical skill: tunnel dissection | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Technical skill: paracentesis | 12 weeks | Custom developed structured rating scale; video-based assessment |
| Technical skill: viscoelastic injection/exchange | 12 weeks | Custom developed structured rating scale; video-based assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed