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Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS)

N

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Surgery-Complications
Cataract

Treatments

Other: Sleep deprivation
Other: Eyesi simulator

Study type

Interventional

Funder types

Other

Identifiers

NCT05722080
AP_JBD_001

Details and patient eligibility

About

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

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • N/A

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

simulator Eyesi - new residents
Other group
Description:
Eyesi simulator learning curve for new ophthalmology residents
Treatment:
Other: Eyesi simulator
simulator Eyesi/sleep deprivation -confirmed residents
Other group
Description:
See how experienced residents perform after sleep deprivation using the Eyesi simulator
Treatment:
Other: Sleep deprivation

Trial contacts and locations

2

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Central trial contact

Jean-Baptiste Ducloyer, M.D; Raoul K Khanna, M.D

Data sourced from clinicaltrials.gov

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