search
Back to results

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

Primary Purpose

Cataract

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Simulation based curriculum
Standard training
Sponsored by
HelpMeSee Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract focused on measuring cataract, MSICS, manual small incision cataract surgery, surgical simulation, simulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • HelpMeSee Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simulation based curriculum

Standard training

Arm Description

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.

Current standard curriculum for resident training.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 19, 2020
Last Updated
June 24, 2020
Sponsor
HelpMeSee Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04450420
Brief Title
Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
Acronym
TCC-PASTE
Official Title
Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
August 16, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HelpMeSee Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, MSICS, manual small incision cataract surgery, surgical simulation, simulation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simulation based curriculum
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard training
Arm Type
Active Comparator
Arm Description
Current standard curriculum for resident training.
Intervention Type
Other
Intervention Name(s)
Simulation based curriculum
Intervention Description
See arm/group description
Intervention Type
Other
Intervention Name(s)
Standard training
Intervention Description
See arm/group description
Primary Outcome Measure Information:
Title
Total surgical errors
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Major surgical errors
Description
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).
Time Frame
12 weeks
Title
Minor surgical errors
Description
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).
Time Frame
12 weeks
Title
Surgical product/outcome assessment: scleral groove
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Surgical product/outcome assessment: tunnel dissection
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Surgical product/outcome assessment: paracentesis
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Surgical product/outcome assessment: viscoelastic injection/exchange
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Surgical product/outcome assessment: keratome entry and extensions
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Overall technical skill for tunnel construction
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Technical skill: scleral groove
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Technical skill: tunnel dissection
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Technical skill: paracentesis
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Technical skill: viscoelastic injection/exchange
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Technical skill: keratome entry and extensions
Description
Custom developed structured rating scale; video-based assessment
Time Frame
12 weeks
Title
Task-specific technical skill: scleral tunnel
Description
ICO-OSCAR:SICS; video-based assessment
Time Frame
12 weeks
Title
Task-specific technical skill: corneal entry
Description
ICO-OSCAR:SICS; video-based assessment
Time Frame
12 weeks
Title
Task-specific technical skill: paracentesis & viscoelastic exchange
Description
ICO-OSCAR:SICS; video-based assessment
Time Frame
12 weeks
Title
Global technical skill
Description
Global indices in ICO-OSCAR:SICS; video-based assessment
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error
Description
Any physical intervention or assistance by supervising surgeon is counted as an additional error
Time Frame
12 weeks
Title
Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error
Description
Any physical intervention or assistance by supervising surgeon is counted as an additional error
Time Frame
12 weeks
Title
Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error
Description
Any physical intervention or assistance by supervising surgeon is counted as an additional error
Time Frame
12 weeks
Title
Incidence of any physical intervention or assistance by supervising surgeon
Description
Each instance of physical intervention or assistance by supervising surgeon is counted as one event.
Time Frame
12 weeks
Title
Incidence of complete intervention or assistance by supervising surgeon
Description
Each instance of ake-over by supervising surgeon for the specific activity or rest of task is counted as one event.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
HelpMeSee Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness

We'll reach out to this number within 24 hrs