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

Cataract Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722080
• Other study ID #: AP_JBD_001
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2023
• Est. completion date: January 9, 2025

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Ducloyer, M.D
• Phone: +33 2 53 48 28 57
• Email: jeanbaptiste.ducloyer[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 9, 2025
• Est. primary completion date: January 9, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Novice resident in Ophthalmology (Axis 1)

• Experienced resident in Opthalmology (Axis 2 )

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• Eyesi simulator
Eyesi simulator learning curve for new ophthalmology residents
• Sleep deprivation
See how experienced residents perform after sleep deprivation using the Eyesi simulator

Locations

Country	Name	City	State
France	CHU Nantes	Nantes
France	CHU Tours	Tours

Sponsors (4)

Lead Sponsor	Collaborator
Nantes University Hospital	Rennes University Hospital, University Hospital, Angers, University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change the score from Baseline at 1 year
Primary	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	Change the score from Baseline at 1 year