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ClinicalTrials.gov ID

NCT05722080

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Feb 15, 2024Actual

Start Date

Jan 9, 2023Actual

Primary Completion Date

Jan 9, 2025Estimated

Completion Date

Jan 9, 2025Estimated

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

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

• Surgery-Complications
• Cataract

• Eyesi simulator
• Sleep deprivation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Primary Purpose

Health Services Research

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

Collaborators

University Hospital, ToursOTHER

Rennes University HospitalOTHER

University Hospital, AngersOTHER_GOV

raoul.khanna@univ-tours.fr