Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2020-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Simulation based curriculum

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.

Group Type EXPERIMENTAL

Simulation based curriculum

Intervention Type OTHER

See arm/group description

Standard training

Current standard curriculum for resident training.

Group Type ACTIVE_COMPARATOR

Standard training

Intervention Type OTHER

See arm/group description

Interventions

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Simulation based curriculum

See arm/group description

Intervention Type OTHER

Standard training

See arm/group description

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes