Clinical trial NCT04450420: Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
Official title: Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Keywords: cataract
MSICS
manual small incision cataract surgery
surgical simulation
simulation
Lead sponsor: HelpMeSee Inc.
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Total surgical errors
timeFrame: 12 weeks
Secondary outcomes:
measure: Major surgical errors
timeFrame: 12 weeks
measure: Minor surgical errors
timeFrame: 12 weeks
measure: Surgical product/outcome assessment: scleral groove
timeFrame: 12 weeks
measure: Surgical product/outcome assessment: tunnel dissection
timeFrame: 12 weeks
measure: Surgical product/outcome assessment: paracentesis
timeFrame: 12 weeks
measure: Surgical product/outcome assessment: viscoelastic injection/exchange
timeFrame: 12 weeks
measure: Surgical product/outcome assessment: keratome entry and extensions
timeFrame: 12 weeks
measure: Overall technical skill for tunnel construction
timeFrame: 12 weeks
measure: Technical skill: scleral groove
timeFrame: 12 weeks
measure: Technical skill: tunnel dissection
timeFrame: 12 weeks
measure: Technical skill: paracentesis
timeFrame: 12 weeks
measure: Technical skill: viscoelastic injection/exchange
timeFrame: 12 weeks
measure: Technical skill: keratome entry and extensions
timeFrame: 12 weeks
measure: Task-specific technical skill: scleral tunnel
timeFrame: 12 weeks
measure: Task-specific technical skill: corneal entry
timeFrame: 12 weeks
measure: Task-specific technical skill: paracentesis & viscoelastic exchange
timeFrame: 12 weeks
measure: Global technical skill
timeFrame: 12 weeks
Other outcomes:
measure: Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error
timeFrame: 12 weeks
measure: Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error
timeFrame: 12 weeks
measure: Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error
timeFrame: 12 weeks
measure: Incidence of any physical intervention or assistance by supervising surgeon
timeFrame: 12 weeks
measure: Incidence of complete intervention or assistance by supervising surgeon
timeFrame: 12 weeks
Locations:
city: New York
country: United States
facility: HelpMeSee Inc.
state: New York
Study officials:
References: