Image

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

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

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study details
    Surgery-Complications
    Cataract

NCT05722080

Nantes University Hospital

22 February 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.