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NCT Number: NCT06799156

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Vitrectomy Vitrectomy Operation Under General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ludwig Maximilian University of Munich

Munich, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Rate of postoperative Adverse Events (AEs)

    Time frame: From 1 day after surgery to the end of enrollment at 90 days postoperatively

    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 (%).

  2. To evaluate the performance of the device

    Time frame: During surgery (intraoperative)

    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 (%).

  3. To evaluate the possible reduction of total surgical time

    Time frame: During surgery (intraoperative)

    Collection of procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge

  4. To evaluate user satisfaction with the device - sutureless procedure

    Time frame: During surgery (intraoperative)

    • Rate of sutureless cataract procedure (cataract and combined subgroups)

  5. 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)

    • 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

  6. To evaluate user satisfaction with the device - success rate

    Time frame: During surgery (intraoperative)

    • Success rate of intended surgical procedures

  7. To evaluate user satisfaction with the device - procedure time

    Time frame: During surgery (intraoperative)

    • Procedure time(s) for subgroups cataract, vitrectomy and combined procedure)

  8. To evaluate user satisfaction with the device - fluid volume

    Time frame: During surgery (intraoperative)

    • Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure)

  9. To evaluate user satisfaction with the device

    Time frame: During surgery (intraoperative)

    • List of all other medical devices used during the procedure

  10. To evaluate user satisfaction with the device - Aspiration

    Time frame: During surgery (intraoperative)

    • 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

  11. To evaluate user satisfaction with the device - sutureless vitrectomy

    Time frame: During surgery (intraoperative)

    • Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):

Other outcomes

  1. Anatomical success (for subgroups vitrectomy and combined procedure):

    Time frame: From surgery until end of treatment at 90 days

    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 (%)

  2. Manifest refraction and BCDVA (sphere and cylinder) (for subgroups cataract, vitrectomy and combined procedure):

    Time frame: At 1 day (Visit 1) and at 90 days (Visit 3)

    Mean monocular distance contrast sensitivity (photopic with and without glare, measured at 4m) at 1 day (visit 1) and 90 days (Visit 3)

  3. Corneal oedema grading (by slit lamp examination) (for subgroups cataract and combined procedure)

    Time frame: from enrollment until end of treatment at 90 days

    Graded on a standardized scale (e.g., 0 = none, 1 = mild, 2 = moderate, 3 = severe) using slit lamp biomicroscopy.

  4. Central macular thickness (for subgroups cataract, vitrectomy and combined procedure: within vitrectomy and combined subgroups, group data by Gauge)

    Time frame: from enrollment until end of treatment at 90 days

    Central macular thickness (CMT) measured by OCT in microns.

  5. Endothelial cell count (ECC)

    Time frame: from enrollment until end of treatment at 90 days

    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.

  6. Endothelial cell density: (for subgroup cataract):

    Time frame: from enrollment until end of treatment at 90 days

    Comparison between pre-op examination and Visit 3 examination.: Endothelial cell density expressed as cells/mm².

  7. Description of wound architecture before IOL implantation from intra-op OCT (for subgroups cataract and combined)

    Time frame: from enrollment until end of treatment at 90 days

    Qualitative OCT imaging of corneal or scleral wound architecture before intraocular lens (IOL) implantation.

  8. Description of sclerotomy wound closure Visit 1 and Visit 3 post-op (OCT images, vitrectomy and combined sub-groups by Gauge)

    Time frame: From 1 day after surgery to the end of enrollment at 90 days postoperatively

    Qualitative evaluation of sclerotomy closure at Visit 1 and Visit 3 post-op using OCT, grouped by gauge size

  9. Fundus examination

    Time frame: from enrollment until end of treatment at 90 days

    Any abnormalities or observations noted during a detailed fundus examination post-operatively

  10. Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):

    Time frame: During surgery (intraoperative)

    Surgeries where pars plana vitrectomy was completed without sutures. Numerator: Sutureless procedures. Denominator: Total procedures in the subgroup.

  11. Rate of sutureless cataract procedure (cataract and combined subgroups):

    Time frame: During surgery (intraoperative)

    Definition: Cataract surgeries completed without sutures. Numerator: Sutureless procedures. Denominator: Total procedures in the subgroup.

  12. Success rate of intended surgical procedures (complete cataract removal, successful retinal re-attachment and macular hole closure by Gauge):

    Time frame: During surgery (intraoperative)

    Numerator: Successfull procedures. Denominator: Total procedures in performed.

  13. Procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge

    Time frame: During surgery (intraoperative)

    • 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

  14. Fluid volume used for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge

    Time frame: During surgery (intraoperative)

    (measured in ml)

    • Total Irrigation fluid (GUI)
    • Total aspiration fluid (GUI)

  15. List of all other medical devices used during the procedure

    Time frame: During surgery (intraoperative)

    List of all other medical devices used during the procedure

    • System components and accessories
    • Cannula gauge size
    • Arcadophta products

  16. Learning curve

    Time frame: During surgery (intraoperative)

    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

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Acronym: Virtuoso1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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