Ophthalmological Virtual Surgery TrainingNCT02559661
Virtual Surgery: Construction of a Training Program and Analysis of Significant Factors for Operating Performance
An observational study of Ophthalmological Virtual Surgery Training, run by Odense University Hospital.
Trial summary
Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation where the surgeon requires much training and where there is an increased risk of operative complications in the early stage. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ophthalmological Virtual Surgery Training
- What is being tested?
- Training on a virtual simulator in eye surgery
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jan 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Substudy A: 1. Group with trained vitreoretinal surgeons (n = 5). 2. Group with future ophthalmologists in training (n = 10). 3. Group of medicine students with limited knowledge of the anatomy and pathology (n = 20). Substudy B: Based on the constructed program in substudy A, five subjects goes through an intensive training program, which terminated when they achieve the same target score as Group 1 in substudy A.
Who may be able to join
- Substudy A:
- Group with trained vitreoretinal surgeons (n = 5).
- Group with future ophthalmologists in training (n = 10).
- Group of medicine students with limited knowledge of the anatomy and pathology (n = 20).
- Substudy B:
- Based on the constructed program in substudy A, five subjects goes through an intensive training program, which terminated when they achieve the same target score as Group 1 in substudy A.
Who cannot join
- All groups that are not as described as above.
About this study
Official title: Virtual Vitreoretinal Surgery: Construction of a Training Program and Analysis of Significant Factors for Operating Performance
Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation where the surgeon requires much training and where there is an increased risk of operative complications in the early stage. For this reason, virtual surgery is suited to help training and subsequent maintenance of operational skills [1, 2].
There are no previously published research in virtual vitreoretinal surgery, but this is nevertheless vital to better surgical training.
Read more
Many surgical disorders - such as retinal detachment - progresses with time, and it is often not known when to ideally operate [3]. On one hand, it may be best to operate early and thereby reduce the risk of disease progression before surgery. On the other hand, it is also important to take into account factors such as the presence of the correct operational expertise as well as the surgeon's fatigue and stress levels. These mentioned matters is difficult to test clinically. With virtual surgery it will be possible to introduce various operational distractions and see what impact it has on operating performance.
The purpose of the study 'Virtual vitreoretinal surgery: construction of a training program and analysis of significant factors for operating performance' is 1) to facilitate the training of future vitreoretinal surgeons by introducing a virtual training program with high construction validity, and 2) to clarify which external conditions affects the performance of trained operator using the virtual training program.
Read the detailed description
Background:
Operations in the retina and removal of the vitreous body (vitrectomy) is a procedure that is in rapid growth. Demographic mix and a rapidly increasing incidence of lifestyle-related diseases such as diabetes mellitus leads to increased operational need [1]. Causes of vitrectomy include bleeding in the vitreous of the eye, retinal detachment, a hole in the macula of the retina (macular hole) and removal of connective tissue (epiretinal membrane) at the macula.
Vitrectomy was previously associated with high risks and were therefore only performed in special cases, but in recent years the operational results have been markedly better - not least due to the introduction of technological advances such as smaller and better instruments. Nevertheless, it is a type of operation that the surgeon requires a long training and an increased risk of operative complications in the early stage. For this reason, virtual surgery is suited to help training and maintaining operational skills [2, 3].
Research Unit of Ophthalmology at Odense University and Southern University received in 2007 a grant from the Velux Foundation for obtaining a EyeSi (eye surgical simulator) Surgical Simulator (VRMagic Gesellschaft mit beschränkter Haftung (GmbH), Mannheim, Germany). This surgical eye simulator has subsequently been a great joy for eye surgeons from across the country who have used the machine to train and maintain operating procedures.
The machine can be used both to train cataract operations, as well as responses in the eye's posterior section (vitreoretinal surgery) surgery of the vitreous body and retina. There is an increasing research activity within EYESI-based virtual eye surgery [4-6], but so far this reserved for training in cataract operations. The investigators have, for example, previously could demonstrate that repetitive training in cataract surgery promotes the surgical learning and enhance the qualifications of future eye surgeons [7]. Subsequently, another Danish group published proposals for specific simulation pass requirements [8], and simulation training is subsequently introduced as part of the training of future cataract surgeons in the country.
There are no previously published research in virtual vitreoretinal surgery, but this is nevertheless vital to better surgical training. The vitreoretinal training modules include exercises in varying degrees of difficulty in numerous areas such as Navigation Training, Forceps Training, Anti-Tremor-Training, bimanual Training, bimanual Scissors Training, Laser Coagulation, Posterior Hyaloid Training, Epiretinal Membrane Peeling, Internal Limiting Membrane (ILM) Training and Retinal Detachment. Due to the many potential exercises it is important to develop a vitreoretinal training program which includes relevant modules at the right level of difficulty.
One of the main requirements for such a program is that it should exhibit high construction validity [9]. Meaning that the program must be able to measure the wanted, which in this case is surgical skills in groups with different levels of competence. It must, in other words, be possible to differentiate trained vitreoretinal surgeons from untrained surgeons. From this it will be possible to develop reference scores, and the program can be implemented in surgical training course.
Many surgical disorders - such as retinal detachment - progresses with time, and it is often not known when to ideally operate [10]. On the one hand, it may be best to operate early and thereby reduce the risk of disease progression before surgery. On the other hand, it is also important to take into account factors such as the presence of the correct operational expertise as well as the surgeon's fatigue and stress levels.
Conditions as last-mentioned clearly is difficult to test clinically and virtual surgery thus allows to design studies that safely allows for testing conditions as sleep deprivation and other operational distractions.
Purpose:
The purpose of this study is 1) to facilitate the training of future vitreoretinal surgeons by introducing a virtual training program with high construction validity, and 2) to clarify which external conditions affects the performance of trained operator using the virtual training program.
Substudy A:
From the training sessions, simulation manuals and guidance from vitreoretinal surgeons, proposals for a virtual vitreoretinal training program is composed including relevant modules in appropriate degree of difficulty.
This program is tested following three groups:
- Group with trained vitreoretinal surgeons (n = 5).
- Group with future ophthalmologists in training (n = 10).
- Group of medicine students with limited knowledge of the anatomy and pathology (n = 20).
Each group should go through the program twice with one to two weeks apart, and the results from the second training session is determined. Subsequently the individual modules construct validity is evaluated, assuming that a given module exhibits high construction validity, if the median score for group 1 is higher than that of group 2, which is in turn higher than that of Group 3 (tested by Cuzicks test for trend).
Modules with high construction validity is then included in the final model.
Substudy B:
Based on the constructed program in substudy A, five subjects goes through an intensive training program, which terminated when they achieve the same target score as Group 1 in substudy A. The target score is now used as reference for subsequent exercises.
The subjects then conducts the training program under the influence of the following operational challenges:
- Operation with non-dominant hand.
- Operation with auditory distraction.
- Operation during nighttime sleep.
- Operation after 12 hours of fasting for solid food.
- Operation after 24 hours of sleep deprivation. It is then calculated which of the five programs, which results in a modified test score compared to score target (tested by Wilcoxon matched signed rank sum test).
- Being tested
- Training on a virtual simulator in eye surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on a virtual simulator in eye surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| Medical students | Students with limited knowledge of the anatomy and pathology of the eye. Receives: Other: Training on a virtual simulator in eye surgery | |
| Ophthalmological trainees | The trainees have never done eye surgery but have a better understanding of the eyes pathology and anatomy than the medical students. Receives: Other: Training on a virtual simulator in eye surgery | |
| Vitreoretinal surgeons | The vitreoretinal surgeons knows the eyes anatomy and pathology well and have training and skills in vitreoretinal surgery. Receives: Other: Training on a virtual simulator in eye surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in the virtual vitreoretinal training program on EyeSi.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ophthalmological Virtual Surgery 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark
- Responsible party
- Principal investigator, Anna Stage Vergmann, Odense University Hospital
- Investigators
- Anna Stage Vergmann, Med. student, Principal investigator, University of Southern DenmarkJakob Grasulund, Prof., DMSci, PhD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559661
- Sponsor's protocol ID
- 49238
- Status last verified
- Mar 2020
- First submitted
- 22 Sep 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Broe R, Rasmussen ML, Frydkjaer-Olsen U, Olsen BS, Mortensen HB, Peto T, Grauslund J. Long-term incidence of vitrectomy and associated risk factors in young Danish patients with Type 1 diabetes: the Danish Cohort of Paediatric Diabetes 1987. Diabet Med. 2015 Apr;32(4):542-5. doi: 10.1111/dme.12628. Epub 2014 Nov 25.
PubMed 25399913Feudner EM, Engel C, Neuhann IM, Petermeier K, Bartz-Schmidt KU, Szurman P. Virtual reality training improves wet-lab performance of capsulorhexis: results of a randomized, controlled study. Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):955-63. doi: 10.1007/s00417-008-1029-7. Epub 2009 Jan 27.
PubMed 19172289Solverson DJ, Mazzoli RA, Raymond WR, Nelson ML, Hansen EA, Torres MF, Bhandari A, Hartranft CD. Virtual reality simulation in acquiring and differentiating basic ophthalmic microsurgical skills. Simul Healthc. 2009 Summer;4(2):98-103. doi: 10.1097/SIH.0b013e318195419e.
PubMed 19444047Mahr MA, Hodge DO. Construct validity of anterior segment anti-tremor and forceps surgical simulator training modules: attending versus resident surgeon performance. J Cataract Refract Surg. 2008 Jun;34(6):980-5. doi: 10.1016/j.jcrs.2008.02.015.
PubMed 18499005Belyea DA, Brown SE, Rajjoub LZ. Influence of surgery simulator training on ophthalmology resident phacoemulsification performance. J Cataract Refract Surg. 2011 Oct;37(10):1756-61. doi: 10.1016/j.jcrs.2011.04.032. Epub 2011 Aug 15.
PubMed 21840683Selvander M, Asman P. Cataract surgeons outperform medical students in Eyesi virtual reality cataract surgery: evidence for construct validity. Acta Ophthalmol. 2013 Aug;91(5):469-74. doi: 10.1111/j.1755-3768.2012.02440.x. Epub 2012 Jun 7.
PubMed 22676143Bergqvist J, Person A, Vestergaard A, Grauslund J. Establishment of a validated training programme on the Eyesi cataract simulator. A prospective randomized study. Acta Ophthalmol. 2014 Nov;92(7):629-34. doi: 10.1111/aos.12383. Epub 2014 Mar 11.
PubMed 24612448Thomsen ASS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-421. doi: 10.1111/aos.12691. Epub 2015 Feb 26.
PubMed 25722080Westen D, Rosenthal R. Quantifying construct validity: two simple measures. J Pers Soc Psychol. 2003 Mar;84(3):608-18. doi: 10.1037//0022-3514.84.3.608.
PubMed 12635920Hajari JN, Kyhnel A, Bech-Azeddine J, la Cour M, Kiilgaard JF. Progression of foveola-on rhegmatogenous retinal detachment. Br J Ophthalmol. 2014 Nov;98(11):1534-8. doi: 10.1136/bjophthalmol-2014-305157. Epub 2014 Jun 24.
PubMed 24963023
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Vitreoretinal Surgery: Construction of a Training Program and Analysis of Significant Factors for Operating Performance
- ClinicalTrials.gov ID
- NCT02559661
- Acronym / sponsor ID
- 49238
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- 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.
Operations in the retina and removal of the vitreous (vitrectomy) is a type of operation where the surgeon requires much training and where there is an increased risk of operative complications in the early stage. For this reason, virtual surgery is suited to help training and subsequent maintenance of operational skills [1, 2].
There are no previously published research in virtual vitreoretinal surgery, but this is nevertheless vital to better surgical training.
Many surgical disorders - such as retinal detachment - progresses with time, and it is often not known when to ideally operate [3]. On one hand, it may be best to operate early and thereby reduce the risk of disease progression before surgery. On the other hand, it is also important to take into account factors such as the presence of the correct operational expertise as well as the surgeon's fatigue and stress levels. These mentioned matters is difficult to test clinically. With virtual surgery it will be possible to introduce various operational distractions and see what impact it has on operating performance.
The purpose of the study 'Virtual vitreoretinal surgery: construction of a training program and analysis of significant factors for operating performance' is 1) to facilitate the training of future vitreoretinal surgeons by introducing a virtual training program with high construction validity, and 2) to clarify which external conditions affects the performance of trained operator using the virtual training program.
Detailed description
Background:
Operations in the retina and removal of the vitreous body (vitrectomy) is a procedure that is in rapid growth. Demographic mix and a rapidly increasing incidence of lifestyle-related diseases such as diabetes mellitus leads to increased operational need [1]. Causes of vitrectomy include bleeding in the vitreous of the eye, retinal detachment, a hole in the macula of the retina (macular hole) and removal of connective tissue (epiretinal membrane) at the macula.
Vitrectomy was previously associated with high risks and were therefore only performed in special cases, but in recent years the operational results have been markedly better - not least due to the introduction of technological advances such as smaller and better instruments. Nevertheless, it is a type of operation that the surgeon requires a long training and an increased risk of operative complications in the early stage. For this reason, virtual surgery is suited to help training and maintaining operational skills [2, 3].
Research Unit of Ophthalmology at Odense University and Southern University received in 2007 a grant from the Velux Foundation for obtaining a EyeSi (eye surgical simulator) Surgical Simulator (VRMagic Gesellschaft mit beschränkter Haftung (GmbH), Mannheim, Germany). This surgical eye simulator has subsequently been a great joy for eye surgeons from across the country who have used the machine to train and maintain operating procedures.
The machine can be used both to train cataract operations, as well as responses in the eye's posterior section (vitreoretinal surgery) surgery of the vitreous body and retina. There is an increasing research activity within EYESI-based virtual eye surgery [4-6], but so far this reserved for training in cataract operations. The investigators have, for example, previously could demonstrate that repetitive training in cataract surgery promotes the surgical learning and enhance the qualifications of future eye surgeons [7]. Subsequently, another Danish group published proposals for specific simulation pass requirements [8], and simulation training is subsequently introduced as part of the training of future cataract surgeons in the country.
There are no previously published research in virtual vitreoretinal surgery, but this is nevertheless vital to better surgical training. The vitreoretinal training modules include exercises in varying degrees of difficulty in numerous areas such as Navigation Training, Forceps Training, Anti-Tremor-Training, bimanual Training, bimanual Scissors Training, Laser Coagulation, Posterior Hyaloid Training, Epiretinal Membrane Peeling, Internal Limiting Membrane (ILM) Training and Retinal Detachment. Due to the many potential exercises it is important to develop a vitreoretinal training program which includes relevant modules at the right level of difficulty.
One of the main requirements for such a program is that it should exhibit high construction validity [9]. Meaning that the program must be able to measure the wanted, which in this case is surgical skills in groups with different levels of competence. It must, in other words, be possible to differentiate trained vitreoretinal surgeons from untrained surgeons. From this it will be possible to develop reference scores, and the program can be implemented in surgical training course.
Many surgical disorders - such as retinal detachment - progresses with time, and it is often not known when to ideally operate [10]. On the one hand, it may be best to operate early and thereby reduce the risk of disease progression before surgery. On the other hand, it is also important to take into account factors such as the presence of the correct operational expertise as well as the surgeon's fatigue and stress levels.
Conditions as last-mentioned clearly is difficult to test clinically and virtual surgery thus allows to design studies that safely allows for testing conditions as sleep deprivation and other operational distractions.
Purpose:
The purpose of this study is 1) to facilitate the training of future vitreoretinal surgeons by introducing a virtual training program with high construction validity, and 2) to clarify which external conditions affects the performance of trained operator using the virtual training program.
Substudy A:
From the training sessions, simulation manuals and guidance from vitreoretinal surgeons, proposals for a virtual vitreoretinal training program is composed including relevant modules in appropriate degree of difficulty.
This program is tested following three groups:
- Group with trained vitreoretinal surgeons (n = 5).
- Group with future ophthalmologists in training (n = 10).
- Group of medicine students with limited knowledge of the anatomy and pathology (n = 20).
Each group should go through the program twice with one to two weeks apart, and the results from the second training session is determined. Subsequently the individual modules construct validity is evaluated, assuming that a given module exhibits high construction validity, if the median score for group 1 is higher than that of group 2, which is in turn higher than that of Group 3 (tested by Cuzicks test for trend).
Modules with high construction validity is then included in the final model.
Substudy B:
Based on the constructed program in substudy A, five subjects goes through an intensive training program, which terminated when they achieve the same target score as Group 1 in substudy A. The target score is now used as reference for subsequent exercises.
The subjects then conducts the training program under the influence of the following operational challenges:
- Operation with non-dominant hand.
- Operation with auditory distraction.
- Operation during nighttime sleep.
- Operation after 12 hours of fasting for solid food.
- Operation after 24 hours of sleep deprivation. It is then calculated which of the five programs, which results in a modified test score compared to score target (tested by Wilcoxon matched signed rank sum test).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical students | – | Other: Training on a virtual simulator in eye surgeryStudents with limited knowledge of the anatomy and pathology of the eye. |
| Ophthalmological trainees | – | Other: Training on a virtual simulator in eye surgeryThe trainees have never done eye surgery but have a better understanding of the eyes pathology and anatomy than the medical students. |
| Vitreoretinal surgeons | – | Other: Training on a virtual simulator in eye surgeryThe vitreoretinal surgeons knows the eyes anatomy and pathology well and have training and skills in vitreoretinal surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Substudy A: 1. Group with trained vitreoretinal surgeons (n = 5). 2. Group with future ophthalmologists in training (n = 10). 3. Group of medicine students with limited knowledge of the anatomy and pathology (n = 20). Substudy B: Based on the constructed program in substudy A, five subjects goes through an intensive training program, which terminated when they achieve the same target score as Group 1 in substudy A.
Key inclusion criteria (6 listed)
- Substudy A:
- Based on the constructed program in substudy A, five subjects goes through an intensive training program, which terminated when they achieve the same target score as Group 1 in substudy A.
Key exclusion criteria (1 listed)
- All groups that are not as described as above.
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 |
|---|---|---|
| Training on a virtual simulator in eye surgery | Other | Medical students, Ophthalmological trainees, Vitreoretinal surgeons |
Primary outcome
Score in the virtual vitreoretinal training program on EyeSi.
Time frame: 2 hours
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 4 Mar 2020.
- Background: PubMed 25399913Broe R, Rasmussen ML, Frydkjaer-Olsen U, Olsen BS, Mortensen HB, Peto T, Grauslund J. Long-term incidence of vitrectomy and associated risk factors in young Danish patients with Type 1 diabetes: the Danish Cohort of Paediatric Diabetes 1987. Diabet Med. 2015 Apr;32(4):542-5. doi: 10.1111/dme.12628. Epub 2014 Nov 25.
- Background: PubMed 19172289Feudner EM, Engel C, Neuhann IM, Petermeier K, Bartz-Schmidt KU, Szurman P. Virtual reality training improves wet-lab performance of capsulorhexis: results of a randomized, controlled study. Graefes Arch Clin Exp Ophthalmol. 2009 Jul;247(7):955-63. doi: 10.1007/s00417-008-1029-7. Epub 2009 Jan 27.
- Background: PubMed 19444047Solverson DJ, Mazzoli RA, Raymond WR, Nelson ML, Hansen EA, Torres MF, Bhandari A, Hartranft CD. Virtual reality simulation in acquiring and differentiating basic ophthalmic microsurgical skills. Simul Healthc. 2009 Summer;4(2):98-103. doi: 10.1097/SIH.0b013e318195419e.
- Background: PubMed 18499005Mahr MA, Hodge DO. Construct validity of anterior segment anti-tremor and forceps surgical simulator training modules: attending versus resident surgeon performance. J Cataract Refract Surg. 2008 Jun;34(6):980-5. doi: 10.1016/j.jcrs.2008.02.015.
- Background: PubMed 21840683Belyea DA, Brown SE, Rajjoub LZ. Influence of surgery simulator training on ophthalmology resident phacoemulsification performance. J Cataract Refract Surg. 2011 Oct;37(10):1756-61. doi: 10.1016/j.jcrs.2011.04.032. Epub 2011 Aug 15.
- Background: PubMed 22676143Selvander M, Asman P. Cataract surgeons outperform medical students in Eyesi virtual reality cataract surgery: evidence for construct validity. Acta Ophthalmol. 2013 Aug;91(5):469-74. doi: 10.1111/j.1755-3768.2012.02440.x. Epub 2012 Jun 7.
- Background: PubMed 24612448Bergqvist J, Person A, Vestergaard A, Grauslund J. Establishment of a validated training programme on the Eyesi cataract simulator. A prospective randomized study. Acta Ophthalmol. 2014 Nov;92(7):629-34. doi: 10.1111/aos.12383. Epub 2014 Mar 11.
- Background: PubMed 25722080Thomsen ASS, Kiilgaard JF, Kjaerbo H, la Cour M, Konge L. Simulation-based certification for cataract surgery. Acta Ophthalmol. 2015 Aug;93(5):416-421. doi: 10.1111/aos.12691. Epub 2015 Feb 26.
- Background: PubMed 12635920Westen D, Rosenthal R. Quantifying construct validity: two simple measures. J Pers Soc Psychol. 2003 Mar;84(3):608-18. doi: 10.1037//0022-3514.84.3.608.
- Background: PubMed 24963023Hajari JN, Kyhnel A, Bech-Azeddine J, la Cour M, Kiilgaard JF. Progression of foveola-on rhegmatogenous retinal detachment. Br J Ophthalmol. 2014 Nov;98(11):1534-8. doi: 10.1136/bjophthalmol-2014-305157. Epub 2014 Jun 24.
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.
Anna Stage Vergmann, Med. student principal investigator
University of Southern Denmark
Jakob Grasulund, Prof., DMSci, PhD study director
University of Southern Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Ophthalmological Virtual Surgery Training, run by Odense University Hospital.
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 6 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 4 Mar 2020. 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?
Score in the virtual vitreoretinal training program on EyeSi. (time frame: 2 hours). 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 NCT02559661, which also lists 10 linked publications.
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 4 Mar 2020.