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

HelpMeSee Inc.

Status and phase: Completed; Phase 2

Conditions: Cataract

Treatments: Other: Simulation based curriculum; Other: Standard training

Study type: Interventional

Funder types: Other

Identifiers

NCT04450420

TCCPASTE

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Simulation based curriculum

Experimental group

Description:

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.

Treatment:

Other: Simulation based curriculum

Standard training

Active Comparator group

Description:

Current standard curriculum for resident training.

Treatment:

Other: Standard training