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

February 14, 2024 updated by: Nantes University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scores on standardized simulator Eyesi assessments
Time Frame: Change the score from Baseline at 1 year
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
Change the score from Baseline at 1 year
Scores on standardized simulator Eyesi assessments after sleep deprivation
Time Frame: Change the score from Baseline at 1 year
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
Change the score from Baseline at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Collaborators

University Hospital, Angers
Rennes University Hospital
University Hospital, Tours

Investigators

  • Principal Investigator: Pierre Lebranchu, M.D, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2023

Primary Completion (Estimated)

January 9, 2025

Study Completion (Estimated)

January 9, 2025

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP_JBD_001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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