CataractVirtuoso1NCT06799156
Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
An observational study of Cataract and Vitrectomy, run by Beaver-Visitec International, Inc. at 1 site in Germany.
Trial summary
This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Vitrectomy, Vitrectomy Operation Under General Anesthesia
- How many people
- 205 participants
- Where
- 1 siteGermany
- Study dates
- 3 Dec 2025to Nov 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patient scheduled for either cataract surgery (subgroup "cataract"), pars-plana vitrectomy surgery, regardless of the indication (subgroup "vitrectomy"), or vitrectomy combined with cataract surgery (subgroup "combined procedure")
Who may be able to join
- Primary or repeat vitrectomy (only applicable to patients scheduled for vitrectomy or combined procedure)
- Patients aged ≥ 18 years
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
Who cannot join
- Patients aged < 18 years
- No post-operative 90 days visit is anticipated
- Patients requiring or having already had scleral buckling
- Patients with ocular comorbidities affecting surgical view including corneal opacities or scar
- Pre-operative endothelial cell count <1500 cells/cm2 (only applicable to patients considered for the cataract subgroup or the combined surgeries subgroup)
- Advanced and secondary glaucoma
Show all 15Show fewer
- History of intraocular inflammation
- Untreated diabetes
- Microphthalmos or macrophthalmos
- Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
- Post-Traumatic eye
- Subluxated lens
- Morganian cataract
- Weak zonules: zonuli lysis or zonula laxa manifest
- Pregnant or nursing females
Trial locations and contacts
1 site in 1 country.
About this study
This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
Read the detailed description
The Virtuoso® DUAL Advanced Vision Solutions system is a multifunctional phacoemulsification-vitrectomy system consisting of equipment and accessories for use in ophthalmic surgeries. The system is indicated for both anterior segment (i.e. phaco-emulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In this study, the system is used within its intended purpose. Study participants will undergo a routine vitrectomy procedure, cataract procedure or combined procedure, depending on their medical needs, using the investigational phaco-vitrectomy system. Data will be collected on the use and functioning of the device, the ability to complete procedures with the device according to the standard of care, and clinical safety and performance outcomes.
- Keywords
- vitrectomy device, vitrectomy, vitrectomy surgery, cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cataract subgroup | The patients recruited in this subgroup will undergo their routine cataract surgery. The Vitrectomy device will be used during surgery during the phacoemulsification phase of the surgery. | |
| Pars-plana Vitrectomy subgroup | The patients in this group will undergo the pars-plana vitrectomy surgery prescribed by their eye doctor. The device will be used to remove the vitreous humor and/or scar tissue which affect the retina. | |
| Combined PPV and Cataract Subgroup | The patients included in this group will undergo combined surgery as recommended by their eye doctor. The device will be used for the phacoemulsification and pars-plana vitrectomy phases of the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to confirm the non-inferiority of the rate of specific intraoperative adverse events compared to the rates reported in the literature.
Objective: The hypothesis being tested in this non-inferiority study of the Virtuoso aims to demonstrate that the safety of this device, in terms of intraoperative surgical adverse event rates, is not significantly worse than the rates already established in the literature for similar devices or surgical techniques. Specifically, the study seeks to prove that the Virtuoso device's safety remains within a clinically acceptable margin of non-inferiority when compared to the adverse event rates observed with comparable phaco-vitrectomy systems.
Measured: During surgery (intraoperative)
Ability to complete the procedure as planned, using the device
The co-primary endpoint is to confirm the non-inferiority of the ability to complete the procedure as planned using the device compared to rates reported in the literature.
The ability to complete the procedure as planned will be defined as the percentage of procedures successfully completed without specific device deficiencies (numerator) divided by the total number of procedures performed (denominator). This rate will be expressed as a percentage (%) and analysed for non-inferiority relative to published data.
Measured: During surgery
Secondary outcomes (11)
Rate of postoperative Adverse Events (AEs)
The rate of Adverse Events (AEs) intra-operatively, defined as the percentage of procedures with at least one identified AE (numerator) out of the total procedures performed (denominator), measured as a percentage (%).
Measured: From 1 day after surgery to the end of enrollment at 90 days postoperatively
To evaluate the performance of the device
Rate of Device Deficiencies (DDs) intra-operatively: The rate of Device Deficiencies (DDs) intra-operatively, defined as the percentage of procedures with at least one identified device deficiency (numerator) out of the total procedures performed (denominator), measured as a percentage (%).
Measured: During surgery (intraoperative)
To evaluate the possible reduction of total surgical time
Collection of procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless procedure
- Rate of sutureless cataract procedure (cataract and combined subgroups)
Measured: During surgery (intraoperative)
To obtain data on the use of other CE-marked BVI products used during the surgery, including silicone oils, perfluorocarbon liquids (PFCLs) and gases
- Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
- List of all other medical devices used during the procedure
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device - success rate
- Success rate of intended surgical procedures
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device - procedure time
- Procedure time(s) for subgroups cataract, vitrectomy and combined procedure)
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device - fluid volume
- Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure)
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device
- List of all other medical devices used during the procedure
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device - Aspiration
- Evaluation of the learning curve for surgeons using the new system: ADE and Aspiration time, Total Procedure Time for subgroups cataract, vitrectomy and combined procedure
Measured: During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless vitrectomy
- Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):
Measured: During surgery (intraoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start3 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 205 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siegfried Priglinger, Dr. med., Principal investigator, LMU MunichMaximilian-Joachim maximilian.gerhardt@med.uni-muenchen.de, Dr.med., Study chair, LMU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799156
- Sponsor's protocol ID
- Virtuoso1
- Acronym
- Virtuoso1
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2025
- Last updated
- 1 Jul 2026
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
- ClinicalTrials.gov ID
- NCT06799156
- Acronym / sponsor ID
- Virtuoso1 / Virtuoso1
- Keywords
- vitrectomy device, vitrectomy, vitrectomy surgery, cataract surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Jan 2025 (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.
This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
Detailed description
The Virtuoso® DUAL Advanced Vision Solutions system is a multifunctional phacoemulsification-vitrectomy system consisting of equipment and accessories for use in ophthalmic surgeries. The system is indicated for both anterior segment (i.e. phaco-emulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In this study, the system is used within its intended purpose. Study participants will undergo a routine vitrectomy procedure, cataract procedure or combined procedure, depending on their medical needs, using the investigational phaco-vitrectomy system. Data will be collected on the use and functioning of the device, the ability to complete procedures with the device according to the standard of care, and clinical safety and performance outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cataract subgroup | – | –The patients recruited in this subgroup will undergo their routine cataract surgery. The Vitrectomy device will be used during surgery during the phacoemulsification phase of the surgery. |
| Pars-plana Vitrectomy subgroup | – | –The patients in this group will undergo the pars-plana vitrectomy surgery prescribed by their eye doctor. The device will be used to remove the vitreous humor and/or scar tissue which affect the retina. |
| Combined PPV and Cataract Subgroup | – | –The patients included in this group will undergo combined surgery as recommended by their eye doctor. The device will be used for the phacoemulsification and pars-plana vitrectomy phases of the surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled for either cataract surgery (subgroup "cataract"), pars-plana vitrectomy surgery, regardless of the indication (subgroup "vitrectomy"), or vitrectomy combined with cataract surgery (subgroup "combined procedure")
Key inclusion criteria (4 listed)
- Primary or repeat vitrectomy (only applicable to patients scheduled for vitrectomy or combined procedure)
- Patients aged ≥ 18 years
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (15 listed)
- Patients aged < 18 years
- No post-operative 90 days visit is anticipated
- Patients requiring or having already had scleral buckling
- Patients with ocular comorbidities affecting surgical view including corneal opacities or scar
- Pre-operative endothelial cell count <1500 cells/cm2 (only applicable to patients considered for the cataract subgroup or the combined surgeries subgroup)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint is to confirm the non-inferiority of the rate of specific intraoperative adverse events compared to the rates reported in the literature.
Time frame: During surgery (intraoperative)
Objective: The hypothesis being tested in this non-inferiority study of the Virtuoso aims to demonstrate that the safety of this device, in terms of intraoperative surgical adverse event rates, is not significantly worse than the rates already established in the literature for similar devices or surgical techniques. Specifically, the study seeks to prove that the Virtuoso device's safety remains within a clinically acceptable margin of non-inferiority when compared to the adverse event rates observed with comparable phaco-vitrectomy systems.
Ability to complete the procedure as planned, using the device
Time frame: During surgery
The co-primary endpoint is to confirm the non-inferiority of the ability to complete the procedure as planned using the device compared to rates reported in the literature. The ability to complete the procedure as planned will be defined as the percentage of procedures successfully completed without specific device deficiencies (numerator) divided by the total number of procedures performed (denominator). This rate will be expressed as a percentage (%) and analysed for non-inferiority relative to published data.
11 secondary outcomes
Rate of postoperative Adverse Events (AEs)
Time frame: From 1 day after surgery to the end of enrollment at 90 days postoperatively
To evaluate the performance of the device
Time frame: During surgery (intraoperative)
To evaluate the possible reduction of total surgical time
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless procedure
Time frame: During surgery (intraoperative)
To obtain data on the use of other CE-marked BVI products used during the surgery, including silicone oils, perfluorocarbon liquids (PFCLs) and gases
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - success rate
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - procedure time
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - fluid volume
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - Aspiration
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless vitrectomy
Time frame: During surgery (intraoperative)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Siegfried Priglinger, Dr. med. principal investigator
LMU Munich
Maximilian-Joachim maximilian.gerhardt@med.uni-muenchen.de, Dr.med. study chair
LMU Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Vitrectomy, run by Beaver-Visitec International, Inc. at 1 site in Germany.
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 4 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
The primary endpoint is to confirm the non-inferiority of the rate of specific intraoperative adverse events compared to the rates reported in the literature. (time frame: During surgery (intraoperative)). 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 1 Jul 2026.