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

NCT06799156 | Not Yet Recruiting

• 1 other identifier: Virtuoso1
• Study Type: observational
• Target: 205
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cataract; Vitrectomy; Vitrectomy Operation Under General Anesthesia

Keywords

vitrectomy device; vitrectomy; vitrectomy surgery; cataract surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Rate of postoperative Adverse Events (AEs)

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

• To evaluate the performance of the device

  During surgery (intraoperative)

• To evaluate the possible reduction of total surgical time

  During surgery (intraoperative)

• To evaluate user satisfaction with the device

  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

  During surgery (intraoperative)

Other Outcomes (16)

• Anatomical success (for subgroups vitrectomy and combined procedure):

  From surgery until end of treatment at 90 days

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

  At 1 day (Visit 1) and at 90 days (Visit 3)

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

  from enrollment until end of treatment at 90 days

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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")

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Siegfried Priglinger, Univ. Prof. Dr. med.

CONTACT

+49 (0)89 4400 53811; siegfried.priglinger@med.uni-muenchen.de

Maximilian-Joachim Gerhardt, Dr.med.

CONTACT

+49 (0)89 4400-53811; maximilian.gerhardt@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 29, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share