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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Other: Simulation based curriculum; Other: Standard training

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10018
      • HelpMeSee Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Simulation based curriculum; Three phases: 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.; Instructor led teaching - didactic training, lab activities to gain familiarity with instruments, simulator based training through deliberate practice, and debriefing with instructor.; Instructor supervised performance of surgery on patients in the operating room.	Other: Simulation based curriculum; See arm/group description
Active Comparator: Standard training; Current standard curriculum for resident training.	Other: Standard training; See arm/group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Surgical product/outcome assessment: scleral groove	Custom developed structured rating scale; video-based assessment	12 weeks
Surgical product/outcome assessment: tunnel dissection	Custom developed structured rating scale; video-based assessment	12 weeks
Surgical product/outcome assessment: paracentesis	Custom developed structured rating scale; video-based assessment	12 weeks
Surgical product/outcome assessment: viscoelastic injection/exchange	Custom developed structured rating scale; video-based assessment	12 weeks
Surgical product/outcome assessment: keratome entry and extensions	Custom developed structured rating scale; video-based assessment	12 weeks
Overall technical skill for tunnel construction	Custom developed structured rating scale; video-based assessment	12 weeks
Technical skill: scleral groove	Custom developed structured rating scale; video-based assessment	12 weeks
Technical skill: tunnel dissection	Custom developed structured rating scale; video-based assessment	12 weeks
Technical skill: paracentesis	Custom developed structured rating scale; video-based assessment	12 weeks
Technical skill: viscoelastic injection/exchange	Custom developed structured rating scale; video-based assessment	12 weeks
Technical skill: keratome entry and extensions	Custom developed structured rating scale; video-based assessment	12 weeks
Task-specific technical skill: scleral tunnel	ICO-OSCAR:SICS; video-based assessment	12 weeks
Task-specific technical skill: corneal entry	ICO-OSCAR:SICS; video-based assessment	12 weeks
Task-specific technical skill: paracentesis & viscoelastic exchange	ICO-OSCAR:SICS; video-based assessment	12 weeks
Global technical skill	Global indices in ICO-OSCAR:SICS; video-based assessment	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: HelpMeSee Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2018
• Primary Completion (Actual): August 16, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 29, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: simulation; cataract; MSICS; manual small incision cataract surgery; surgical simulation
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: TCCPASTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No