Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Cataract Clinical Trial

— TCC-PASTE  

Official title:

Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04450420
• Other study ID #: TCCPASTE
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: June 2020
• Source: HelpMeSee Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2020
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Simulation based curriculum
See arm/group description
• Standard training
See arm/group description

Locations

Country	Name	City	State
United States	HelpMeSee Inc.	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
HelpMeSee Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error	Any physical intervention or assistance by supervising surgeon is counted as an additional error	12 weeks
Other	Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error	Any physical intervention or assistance by supervising surgeon is counted as an additional error	12 weeks
Other	Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error	Any physical intervention or assistance by supervising surgeon is counted as an additional error	12 weeks
Other	Incidence of any physical intervention or assistance by supervising surgeon	Each instance of physical intervention or assistance by supervising surgeon is counted as one event.	12 weeks
Other	Incidence of complete intervention or assistance by supervising surgeon	Each instance of ake-over by supervising surgeon for the specific activity or rest of task is counted as one event.	12 weeks
Primary	Total surgical errors	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).	12 weeks
Secondary	Major surgical errors	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).	12 weeks
Secondary	Minor surgical errors	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).	12 weeks
Secondary	Surgical product/outcome assessment: scleral groove	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Surgical product/outcome assessment: tunnel dissection	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Surgical product/outcome assessment: paracentesis	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Surgical product/outcome assessment: viscoelastic injection/exchange	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Surgical product/outcome assessment: keratome entry and extensions	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Overall technical skill for tunnel construction	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Technical skill: scleral groove	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Technical skill: tunnel dissection	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Technical skill: paracentesis	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Technical skill: viscoelastic injection/exchange	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Technical skill: keratome entry and extensions	Custom developed structured rating scale; video-based assessment	12 weeks
Secondary	Task-specific technical skill: scleral tunnel	ICO-OSCAR:SICS; video-based assessment	12 weeks
Secondary	Task-specific technical skill: corneal entry	ICO-OSCAR:SICS; video-based assessment	12 weeks
Secondary	Task-specific technical skill: paracentesis & viscoelastic exchange	ICO-OSCAR:SICS; video-based assessment	12 weeks
Secondary	Global technical skill	Global indices in ICO-OSCAR:SICS; video-based assessment	12 weeks