Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device (Virtuoso1)

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Vitrectomy; Vitrectomy Operation Under General Anesthesia

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 Type: Observational
• Enrollment (Estimated): 205

Contacts and Locations

• Study Contact: Name: Maximilian-Joachim Gerhardt, Dr.med.; Phone Number: +49 (0)89 4400-53811; Email: maximilian.gerhardt@med.uni-muenchen.de
• Study Contact Backup: Name: Siegfried Priglinger, Dr. med.; Phone Number: +49 (0)89 4400 53811; Email: siegfried.priglinger@med.uni-muenchen.de

Study Locations

• Germany
  • Munich, Germany
    • Recruiting
    • Ludwig Maximilian University of Munich
    • Contact: Maximilian Gerhardt, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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")

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	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 (%).	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	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	During surgery (intraoperative)
To evaluate user satisfaction with the device	- List of all other medical devices used during the procedure	During surgery (intraoperative)
To evaluate user satisfaction with the device - sutureless procedure	- Rate of sutureless cataract procedure (cataract and combined subgroups)	During surgery (intraoperative)
To evaluate user satisfaction with the device - success rate	- Success rate of intended surgical procedures	During surgery (intraoperative)
To evaluate user satisfaction with the device - procedure time	- Procedure time(s) for subgroups cataract, vitrectomy and combined procedure)	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)	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	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):	During surgery (intraoperative)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical success (for subgroups vitrectomy and combined procedure):	Achievement of intended anatomical outcomes, such as retinal reattachment expressed as the number of successful procedures (numerator) out of the total performed (denominator), measured as percentage (%)	From surgery until end of treatment at 90 days
Manifest refraction and BCDVA (sphere and cylinder) (for subgroups cataract, vitrectomy and combined procedure):	Mean monocular distance contrast sensitivity (photopic with and without glare, measured at 4m) at 1 day (visit 1) and 90 days (Visit 3)	At 1 day (Visit 1) and at 90 days (Visit 3)
Corneal oedema grading (by slit lamp examination) (for subgroups cataract and combined procedure)	Graded on a standardized scale (e.g., 0 = none, 1 = mild, 2 = moderate, 3 = severe) using slit lamp biomicroscopy.	from enrollment until end of treatment at 90 days
Central macular thickness (for subgroups cataract, vitrectomy and combined procedure: within vitrectomy and combined subgroups, group data by Gauge)	Central macular thickness (CMT) measured by OCT in microns.	from enrollment until end of treatment at 90 days
Endothelial cell count (ECC)	Defined as the mean change in cell density from baseline to Visit 2, measured in cells per square millimeter (cells/mm²), for subgroups undergoing cataract surgery and combined procedures.	from enrollment until end of treatment at 90 days
Endothelial cell density: (for subgroup cataract):	Comparison between pre-op examination and Visit 3 examination.: Endothelial cell density expressed as cells/mm².	from enrollment until end of treatment at 90 days
Description of wound architecture before IOL implantation from intra-op OCT (for subgroups cataract and combined)	Qualitative OCT imaging of corneal or scleral wound architecture before intraocular lens (IOL) implantation.	from enrollment until end of treatment at 90 days
Description of sclerotomy wound closure Visit 1 and Visit 3 post-op (OCT images, vitrectomy and combined sub-groups by Gauge)	Qualitative evaluation of sclerotomy closure at Visit 1 and Visit 3 post-op using OCT, grouped by gauge size	From 1 day after surgery to the end of enrollment at 90 days postoperatively
Fundus examination	Any abnormalities or observations noted during a detailed fundus examination post-operatively	from enrollment until end of treatment at 90 days
Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):	Surgeries where pars plana vitrectomy was completed without sutures. Numerator: Sutureless procedures. Denominator: Total procedures in the subgroup.	During surgery (intraoperative)
Rate of sutureless cataract procedure (cataract and combined subgroups):	Definition: Cataract surgeries completed without sutures. Numerator: Sutureless procedures. Denominator: Total procedures in the subgroup.	During surgery (intraoperative)
Success rate of intended surgical procedures (complete cataract removal, successful retinal re-attachment and macular hole closure by Gauge):	Numerator: Successfull procedures. Denominator: Total procedures in performed.	During surgery (intraoperative)
Procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge	Set-up time; Total Aspiration time (GUI); Phacoemulsification time (cataract and combined subgroups only) (intended as time in P3, from GUI); Total Procedure Time : to be associated with gauge size and cataract hardness. Time measurements for total procedure steps measured in seconds	During surgery (intraoperative)
Fluid volume used for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge	(measured in ml); Total Irrigation fluid (GUI); Total aspiration fluid (GUI)	During surgery (intraoperative)
List of all other medical devices used during the procedure	List of all other medical devices used during the procedure; System components and accessories; Cannula gauge size; Arcadophta products	During surgery (intraoperative)
Learning curve	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	During surgery (intraoperative)

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: Siegfried Priglinger, Dr. med., LMU Munich; Study Chair: Maximilian-Joachim maximilian.gerhardt@med.uni-muenchen.de, Dr.med., LMU Munich

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cataract surgery; vitrectomy; vitrectomy surgery; vitrectomy device
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: Virtuoso1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No