NCT05722080

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

December 22, 2022

Last Update Submit

February 14, 2024

Conditions

Surgery-ComplicationsCataract

Keywords

Ophthalmologic Surgical ProceduresCataractsimulation trainingEyesi simulatorlearning curvesleepdeprivationprofessionalism

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

simulator Eyesi - new residents

OTHER

Eyesi simulator learning curve for new ophthalmology residents

Other: Eyesi simulator

simulator Eyesi/sleep deprivation -confirmed residents

OTHER

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

Other: Sleep deprivation

Interventions

Eyesi simulatorOTHER

Eyesi simulator learning curve for new ophthalmology residents

simulator Eyesi - new residents
Sleep deprivationOTHER

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

simulator Eyesi/sleep deprivation -confirmed residents

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Nantes

Nantes, 44000, France

RECRUITING

CHU Tours

Tours, 37000, France

RECRUITING

Related Publications (1)

  • Ducloyer JB, Poinas A, Duchesne L, Caillet P, Ivan C, Lejus-Bourdeau C, Limousin N, Desmidt T, Pladys P, Pisella PJ, Bernard A, Lardy H, Gohier P, Martin L, Mouriaux F, Lebranchu P, Khanna RK; E3CAPS Group. Educational Concerns About the Safety of Cataract Surgery During Residency: The E3CAPS Pedagogic Study. Ophthalmol Ther. 2023 Oct;12(5):2801-2812. doi: 10.1007/s40123-023-00774-1. Epub 2023 Aug 2.

    PMID: 37531031DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Pierre Lebranchu, M.D

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Baptiste Ducloyer, M.D

CONTACT

+33 2 53 48 28 57jeanbaptiste.ducloyer@chu-nantes.fr

Raoul K Khanna, M.D

CONTACT

raoul.khanna@univ-tours.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

February 10, 2023

Study Start

January 9, 2023

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

FR(2)