Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS) (E3CAPS)
Primary Purpose
Surgery-Complications, Cataract
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Eyesi simulator
Sleep deprivation
Sponsored by
About this trial
This is an interventional health services research trial for Surgery-Complications focused on measuring Ophthalmologic Surgical Procedures, Cataract, simulation training, Eyesi simulator, learning curve, sleep, deprivation, professionalism
Eligibility Criteria
Inclusion Criteria: Novice resident in Ophthalmology (Axis 1) Experienced resident in Opthalmology (Axis 2 ) Exclusion Criteria: N/A
Sites / Locations
- CHU NantesRecruiting
- CHU ToursRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
simulator Eyesi - new residents
simulator Eyesi/sleep deprivation -confirmed residents
Arm Description
Eyesi simulator learning curve for new ophthalmology residents
See how experienced residents perform after sleep deprivation using the Eyesi simulator
Outcomes
Primary Outcome Measures
Scores on standardized simulator Eyesi assessments
Average score of standardized evaluations on EyeSi simulator. The scale title is "EyeSi score". The scores range from 0 to 100, better outcome being positively correlated with a higher score
Scores on standardized simulator Eyesi assessments after sleep deprivation
Average score of standardized evaluations on EyeSi simulator after sleep deprivation. The scale title is "EyeSi score". The scores range from 0 to 100, better outcome being positively correlated with a higher score
Secondary Outcome Measures
Full Information
NCT ID
NCT05722080
First Posted
December 22, 2022
Last Updated
July 26, 2023
Sponsor
Nantes University Hospital
Collaborators
University Hospital, Tours, Rennes University Hospital, University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT05722080
Brief Title
Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS)
Acronym
E3CAPS
Official Title
E3CAPS: Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator: Learning Curve and Impact of Sleep Deprivation on Residents in Ophthalmology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 9, 2025 (Anticipated)
Study Completion Date
January 9, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
University Hospital, Tours, Rennes University Hospital, University Hospital, Angers
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
The aim of this project is to reduce the risks of cataract surgery using the EyeSi simulator Axis 1: to model the learning curve of novice residents in Ophthalmology who follow the training program recommended by the "Collège des Ophtalmologistes niversitaires de France" (COUF) in order to help creating a "licence to operate" Axis 2: to evaluate the impact of sleep deprivation on the surgical performance of experienced residents in Ophthalmology
Detailed Description
Axis 1 (15 residents): Learning curve Each resident will perform four 2-hour learning sessions, under the supervision of an experienced cataract surgery trainer. Each resident will perform a standardized assessment at the beginning of the first session with the collection of scores at each surgical stage and the calculation of an average score simulating a complete surgery. This standardized assessment will then be repeated at the end of each of the 4 training sessions. These five points of measurement will make it possible to produce a learning curve for each surgical stage and for the average score simulating a complete surgery.
Axis 2 (25 residents): Sleep deprivation
1st session: In order to include the "experienced" residents and to limit the bias related to the learning curve of the cognitive tests and the surgical procedure
3 normed assessments in autonomy to determine the average score for each resident
3 trials of the Test for Attentional Performance (TAP) with parallel versions to limit test-retest learning bias
2nd session: No sleep deprivation
Sleep assessment by actimetry the night before the session (MotionWatch 8©, camntech®, validated as an alternative method to the reference method which is polysomnography)
Epworth sleepiness score
Visual Analogue Scale for Self-Rated Fatigue
Attentional performance tests TAP
3 standardized evaluations on Eyesi in the morning and in the afternoon
3rd session: sleep deprivation (< 7 hours) after a working day
Sleep evaluation by actimetry the night before the session (MotionWatch 8©, camntech®)
Epworth sleepiness score
Self-rated visual analogue scale for fatigue
Attentional performance tests TAP
3 Eyesi standardized evaluations in the morning and in the afternoon
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery-Complications, Cataract
Keywords
Ophthalmologic Surgical Procedures, Cataract, simulation training, Eyesi simulator, learning curve, sleep, deprivation, professionalism
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
First arm to model the learning curve of opthalmologist residents Second arm to show the impact of sleep deprivation on the surgical performance of experienced opthalmologist residents
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
simulator Eyesi - new residents
Arm Type
Other
Arm Description
Eyesi simulator learning curve for new ophthalmology residents
Arm Title
simulator Eyesi/sleep deprivation -confirmed residents
Arm Type
Other
Arm Description
See how experienced residents perform after sleep deprivation using the Eyesi simulator
Intervention Type
Other
Intervention Name(s)
Eyesi simulator
Intervention Description
Eyesi simulator learning curve for new ophthalmology residents
Intervention Type
Other
Intervention Name(s)
Sleep deprivation
Intervention Description
See how experienced residents perform after sleep deprivation using the Eyesi simulator
Primary Outcome Measure Information:
Title
Scores on standardized simulator Eyesi assessments
Description
Average score of standardized evaluations on EyeSi simulator. The scale title is "EyeSi score". The scores range from 0 to 100, better outcome being positively correlated with a higher score
Time Frame
Change the score from Baseline at 1 year
Title
Scores on standardized simulator Eyesi assessments after sleep deprivation
Description
Average score of standardized evaluations on EyeSi simulator after sleep deprivation. The scale title is "EyeSi score". The scores range from 0 to 100, better outcome being positively correlated with a higher score
Time Frame
Change the score from Baseline at 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Novice resident in Ophthalmology (Axis 1)
Experienced resident in Opthalmology (Axis 2 )
Exclusion Criteria:
N/A
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Baptiste Ducloyer, M.D
Phone
+33 2 53 48 28 57
Ext
CHU Nantes
Email
jeanbaptiste.ducloyer@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Raoul K Khanna, M.D
Email
raoul.khanna@univ-tours.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Lebranchu, M.D
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Ducloyer, MD
Email
jeanbaptiste.ducloyer@chu-nantes.fr
Phone
+33 2 53 48 28 57
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raoul Kanav Khanna, MD
Email
raoul.khanna@univ-tours.fr
Phone
+33 2 47 47 47 47
12. IPD Sharing Statement
Learn more about this trial
Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS)
We'll reach out to this number within 24 hrs