Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
TCC-PASTE
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 19, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedJune 29, 2020
June 1, 2020
12 months
June 19, 2020
June 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (17)
Major surgical errors
12 weeks
Minor surgical errors
12 weeks
Surgical product/outcome assessment: scleral groove
12 weeks
Surgical product/outcome assessment: tunnel dissection
12 weeks
Surgical product/outcome assessment: paracentesis
12 weeks
- +12 more secondary outcomes
Other Outcomes (5)
Incidence of any surgical error or self-reported intervention by supervising surgeon to prevent error
12 weeks
Incidence of major surgical error or self-reported intervention by supervising surgeon to prevent error
12 weeks
Incidence of minor surgical error or self-reported intervention by supervising surgeon to prevent error
12 weeks
- +2 more other outcomes
Study Arms (2)
Simulation based curriculum
EXPERIMENTALThree 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.
Standard training
ACTIVE COMPARATORCurrent standard curriculum for resident training.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HelpMeSee Inc.lead
Study Sites (1)
HelpMeSee Inc.
New York, New York, 10018, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2020
First Posted
June 29, 2020
Study Start
August 28, 2018
Primary Completion
August 16, 2019
Study Completion
June 1, 2020
Last Updated
June 29, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share