Clinical trial NCT05722080: Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (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
Overall status: RECRUITING
Phase: NA
Conditions: Surgery-Complications
Cataract
Keywords: Ophthalmologic Surgical Procedures
Cataract
simulation training
Eyesi simulator
learning curve
sleep
deprivation
professionalism
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Tours
name: Rennes University Hospital
name: University Hospital, Angers
First posted: 2023-02-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: Inclusion Criteria:

* Novice resident in Ophthalmology (Axis 1)
* Experienced resident in Opthalmology (Axis 2 )

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Scores on standardized simulator Eyesi assessments
timeFrame: Change the score from Baseline at 1 year
measure: Scores on standardized simulator Eyesi assessments after sleep deprivation
timeFrame: Change the score from Baseline at 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Nantes University Hospital
name: Pierre Lebranchu, M.D
role: PRINCIPAL_INVESTIGATOR
References: