CataractPhase 2TCC-PASTENCT04450420
Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
A Phase 2 study testing Simulation based curriculum and Standard training in people with Cataract, run by HelpMeSee Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Simulation based curriculum and Standard training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2018to 1 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cataract
- Being tested
- Simulation based curriculum, Standard training
- Keywords
- cataract, MSICS, manual small incision cataract surgery, surgical simulation, simulation
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation based curriculumOther
See arm/group description
Standard trainingOther
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Simulation based curriculum | Experimental | 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. Receives: Other: Simulation based curriculum |
| Standard training | Active comparator | Current standard curriculum for resident training. Receives: Other: Standard training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (17)
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).
Measured: 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).
Measured: 12 weeks
Surgical product/outcome assessment: scleral groove
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Surgical product/outcome assessment: tunnel dissection
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Surgical product/outcome assessment: paracentesis
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Surgical product/outcome assessment: viscoelastic injection/exchange
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Surgical product/outcome assessment: keratome entry and extensions
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Overall technical skill for tunnel construction
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Technical skill: scleral groove
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Technical skill: tunnel dissection
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Technical skill: paracentesis
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Technical skill: viscoelastic injection/exchange
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Technical skill: keratome entry and extensions
Custom developed structured rating scale; video-based assessment
Measured: 12 weeks
Task-specific technical skill: scleral tunnel
ICO-OSCAR:SICS; video-based assessment
Measured: 12 weeks
Task-specific technical skill: corneal entry
ICO-OSCAR:SICS; video-based assessment
Measured: 12 weeks
Task-specific technical skill: paracentesis & viscoelastic exchange
ICO-OSCAR:SICS; video-based assessment
Measured: 12 weeks
Global technical skill
Global indices in ICO-OSCAR:SICS; video-based assessment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start28 Aug 2018
- Primary completion16 Aug 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HelpMeSee Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450420
- Sponsor's protocol ID
- TCCPASTE
- Acronym
- TCC-PASTE
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tunnel Construction Course Pilot Assessment of Simulation-based Training Effectiveness
- ClinicalTrials.gov ID
- NCT04450420
- Acronym / sponsor ID
- TCC-PASTE / TCCPASTE
- Conditions
- Cataract
- Keywords
- cataract, MSICS, manual small incision cataract surgery, surgical simulation, simulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HelpMeSee Inc.University, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation based curriculum | Experimental | Other: Simulation based curriculumThree 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 comparator | Other: Standard trainingCurrent standard curriculum for resident training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation based curriculumSee arm/group description | Other | Simulation based curriculum |
| Standard trainingSee arm/group description | Other | Standard training |
Primary outcome
Total surgical errors
Time frame: 12 weeks
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).
17 secondary outcomes
Major surgical errors
Time frame: 12 weeks
Minor surgical errors
Time frame: 12 weeks
Surgical product/outcome assessment: scleral groove
Time frame: 12 weeks
Surgical product/outcome assessment: tunnel dissection
Time frame: 12 weeks
Surgical product/outcome assessment: paracentesis
Time frame: 12 weeks
Surgical product/outcome assessment: viscoelastic injection/exchange
Time frame: 12 weeks
Surgical product/outcome assessment: keratome entry and extensions
Time frame: 12 weeks
Overall technical skill for tunnel construction
Time frame: 12 weeks
Technical skill: scleral groove
Time frame: 12 weeks
Technical skill: tunnel dissection
Time frame: 12 weeks
Technical skill: paracentesis
Time frame: 12 weeks
Technical skill: viscoelastic injection/exchange
Time frame: 12 weeks
Technical skill: keratome entry and extensions
Time frame: 12 weeks
Task-specific technical skill: scleral tunnel
Time frame: 12 weeks
Task-specific technical skill: corneal entry
Time frame: 12 weeks
Task-specific technical skill: paracentesis & viscoelastic exchange
Time frame: 12 weeks
Global technical skill
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simulation based curriculum and Standard training in people with Cataract, run by HelpMeSee Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total surgical errors (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.