Surgery-ComplicationsE3CAPSNCT05722080
Improvement of the Safety of Care in Cataract Surgery Teaching on Eyesi Simulator (E3CAPS)
A study testing Eyesi simulator and Sleep deprivation in people with Surgery-Complications and Cataract, run by Nantes University Hospital at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery-Complications, Cataract
- What is being tested?
- Eyesi simulator and Sleep deprivation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Jan 2023to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Novice resident in Ophthalmology (Axis 1)
- Experienced resident in Opthalmology (Axis 2 )
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
Jean-Baptiste Ducloyer, M.D contact
Raoul K Khanna, M.D contact
France2 sites, 2 recruiting
- Recruiting
CHU Nantes
Nantes, 44000
Jean-Baptiste Ducloyer, MD, jeanbaptiste.ducloyer@chu-nantes.fr
+33 2 53 48 28 57
- Recruiting
CHU Tours
Tours, 37000
Raoul Kanav Khanna, MD, raoul.khanna@univ-tours.fr
+33 2 47 47 47 47
About this study
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
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
Read the 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
- Conditions
- Surgery-Complications, Cataract
- Being tested
- Eyesi simulator, Sleep deprivation
- Keywords
- Ophthalmologic Surgical Procedures, Cataract, simulation training, Eyesi simulator, learning curve, sleep, deprivation, professionalism
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyesi simulatorOther
Eyesi simulator learning curve for new ophthalmology residents
Sleep deprivationOther
See how experienced residents perform after sleep deprivation using the Eyesi simulator
| Study group | Role | What they receive |
|---|---|---|
| simulator Eyesi - new residents | Other | Eyesi simulator learning curve for new ophthalmology residents Receives: Other: Eyesi simulator |
| simulator Eyesi/sleep deprivation -confirmed residents | Other | See how experienced residents perform after sleep deprivation using the Eyesi simulator Receives: Other: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change the score from Baseline at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start9 Jan 2023
- Primary completion9 Jan 2025 (estimated)
- Study completion9 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Lebranchu, M.D, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722080
- Sponsor's protocol ID
- AP_JBD_001
- Acronym
- E3CAPS
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37531031
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05722080
- Acronym / sponsor ID
- E3CAPS / AP_JBD_001
- Conditions
- Surgery-Complications, Cataract
- Keywords
- Ophthalmologic Surgical Procedures, Cataract, simulation training, Eyesi simulator, learning curve, sleep, deprivation, professionalism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Tours, Rennes University Hospital, University Hospital, Angers
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 9 Jan 2025 (estimated)
- Study completion
- 9 Jan 2025 (estimated)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| simulator Eyesi - new residents | Other | Other: Eyesi simulatorEyesi simulator learning curve for new ophthalmology residents |
| simulator Eyesi/sleep deprivation -confirmed residents | Other | Other: Sleep deprivationSee how experienced residents perform after sleep deprivation using the Eyesi simulator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Novice resident in Ophthalmology (Axis 1)
- Experienced resident in Opthalmology (Axis 2 )
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eyesi simulatorEyesi simulator learning curve for new ophthalmology residents | Other | simulator Eyesi - new residents |
| Sleep deprivationSee how experienced residents perform after sleep deprivation using the Eyesi simulator | Other | simulator Eyesi/sleep deprivation -confirmed residents |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Derived from this study: PubMed 37531031Ducloyer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste Ducloyer, M.D contact
Raoul K Khanna, M.D contact
Pierre Lebranchu, M.D principal investigator
Nantes University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyesi simulator and Sleep deprivation in people with Surgery-Complications and Cataract, run by Nantes University Hospital at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste Ducloyer, M.D (+33 2 53 48 28 57 ext. CHU Nantes, jeanbaptiste.ducloyer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on standardized simulator Eyesi assessments (time frame: Change the score from Baseline at 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05722080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.