Simulator-based Medical Skill TrainingNCT04157023
Simulator Training for Direct Ophthalmoscopy
A study testing Simulator-based Training of Direct Ophthalmoscopy in people with Simulator-based Medical Skill Training, run by University Hospital Tuebingen.
Trial summary
Evaluation of a digital simulator to train diagnostic skills in Ophthalmology Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulator-based Medical Skill Training
- What is being tested?
- Simulator-based Training of Direct Ophthalmoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2017
- 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
- Medical student or Ophthalmologist or Neonatologist or Neurologist or Neurosurgeon
- Willing to participate to the study
- Consent to evaluate the measured data
Who cannot join
- age <18 years
About this study
Official title: Direct-Ophthalmoscopy-Simulator-Study
Evaluation of a digital simulator to train diagnostic skills in Ophthalmology
Read the detailed description
Direct Ophthalmoscopy is an important tool to detect pathologies e.g. on the optic nerve head. The training of the needed skills is made conventionally in most cases. In such the training sessions students examine each other after dilating one pupil. Examining of patients with pathologies is very important, but in many cases not very easy without any experience.
Simulators are of growing impact to teach diagnostic or surgical skills. A digital simulator with virtual reality technology is used to teach the skills to unexperienced examiners. The head-eye-hand-coordination can be trained without any stress.
- Conditions
- Simulator-based Medical Skill Training
- Being tested
- Simulator-based Training of Direct Ophthalmoscopy
- Keywords
- simulator, medical skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator-based Training of Direct OphthalmoscopyDevice
A digital simulator is used to teach the skills of direct ophthalmoscopy
| Study group | Role | What they receive |
|---|---|---|
| Medical Students | Other | Simulator training of 7 patient cases adapted to medical students. Receives: Device: Simulator-based Training of Direct Ophthalmoscopy |
| Ophthalmologist | Other | Simulator training of 7 patient cases adapted to ophthalmologists. Receives: Device: Simulator-based Training of Direct Ophthalmoscopy |
| Neurologist/Neurosurgeon/Neonatologist | Other | Simulator training of 7 patient cases adapted to neurologists, neurosurgeons and neonatologists. Receives: Device: Simulator-based Training of Direct Ophthalmoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total examined area
The area that was examined (light on retina) by participants was measured [percent of total area].
Measured: 1 hour
Efficiency
Ratio of examination time (light in pupil) and total examined area [ratio]
Measured: 1 hour
Secondary outcomes (2)
Learning effect
Total examined area results and efficiency ratios were compared between simulator case 1 and simulator case 5.
Measured: 1 hour
Questionnaire
A questionnaire was used to measure the self-evaluation of the trained persons
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulator-based Medical Skill TrainingStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Three groups of participants are made. Group 1: Medical Students Group 2: Ophthalmologists Group 3: Neonatologists/Neurologists/Neurosurgeons
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Martin Leitritz, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157023
- Sponsor's protocol ID
- Simulator
- Status last verified
- Nov 2019
- First submitted
- 1 Nov 2019
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct-Ophthalmoscopy-Simulator-Study
- ClinicalTrials.gov ID
- NCT04157023
- Acronym / sponsor ID
- Simulator
- Conditions
- Simulator-based Medical Skill Training
- Keywords
- simulator, medical skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Nov 2019 (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.
Evaluation of a digital simulator to train diagnostic skills in Ophthalmology
Detailed description
Direct Ophthalmoscopy is an important tool to detect pathologies e.g. on the optic nerve head. The training of the needed skills is made conventionally in most cases. In such the training sessions students examine each other after dilating one pupil. Examining of patients with pathologies is very important, but in many cases not very easy without any experience.
Simulators are of growing impact to teach diagnostic or surgical skills. A digital simulator with virtual reality technology is used to teach the skills to unexperienced examiners. The head-eye-hand-coordination can be trained without any stress.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three groups of participants are made. Group 1: Medical Students Group 2: Ophthalmologists Group 3: Neonatologists/Neurologists/Neurosurgeons
| Arm | Type | Receives |
|---|---|---|
| Medical Students | Other | Device: Simulator-based Training of Direct OphthalmoscopySimulator training of 7 patient cases adapted to medical students. |
| Ophthalmologist | Other | Device: Simulator-based Training of Direct OphthalmoscopySimulator training of 7 patient cases adapted to ophthalmologists. |
| Neurologist/Neurosurgeon/Neonatologist | Other | Device: Simulator-based Training of Direct OphthalmoscopySimulator training of 7 patient cases adapted to neurologists, neurosurgeons and neonatologists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Medical student or Ophthalmologist or Neonatologist or Neurologist or Neurosurgeon
- Willing to participate to the study
- Consent to evaluate the measured data
Key exclusion criteria (1 listed)
- age <18 years
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 |
|---|---|---|
| Simulator-based Training of Direct OphthalmoscopyA digital simulator is used to teach the skills of direct ophthalmoscopy | Device | Medical Students, Neurologist/Neurosurgeon/Neonatologist, Ophthalmologist |
Primary outcome
Total examined area
Time frame: 1 hour
The area that was examined (light on retina) by participants was measured [percent of total area].
Efficiency
Time frame: 1 hour
Ratio of examination time (light in pupil) and total examined area [ratio]
2 secondary outcomes
Learning effect
Time frame: 1 hour
Questionnaire
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Simulator-based Training of Direct Ophthalmoscopy in people with Simulator-based Medical Skill Training, run by University Hospital Tuebingen.
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 3 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: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total examined area (time frame: 1 hour). 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?
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 8 Nov 2019.