Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Completed · Phase 2

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT04450420

Run by

HelpMeSee Inc.

People needed

24

Starts

2018-08-28

Expected to finish

2020-06-01

Last updated by the study team

2020-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• HelpMeSee Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

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