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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05722080
Acronym
E3CAPS
Enrollment
40
Registered
2023-02-10
Start date
2023-01-09
Completion date
2025-01-09
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Surgery-Complications

Keywords

Ophthalmologic Surgical Procedures, Cataract, simulation training, Eyesi simulator, learning curve, sleep, deprivation, professionalism

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

Interventions

OTHEREyesi simulator

Eyesi simulator learning curve for new ophthalmology residents

OTHERSleep deprivation

See how experienced residents perform after sleep deprivation using the Eyesi simulator

Sponsors

University Hospital, Tours
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
University Hospital, Angers
CollaboratorOTHER_GOV
Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

First arm to model the learning curve of opthalmologist residents Second arm to show the impact of sleep deprivation on the surgical performance of experienced opthalmologist residents

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frameDescription
Scores on standardized simulator Eyesi assessmentsChange the score from Baseline at 1 yearAverage 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
Scores on standardized simulator Eyesi assessments after sleep deprivationChange the score from Baseline at 1 yearAverage 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

Countries

France

Contacts

Primary ContactJean-Baptiste Ducloyer, M.D
jeanbaptiste.ducloyer@chu-nantes.fr+33 2 53 48 28 57
Backup ContactRaoul K Khanna, M.D
raoul.khanna@univ-tours.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026