RecruitingNot Applicable

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

Germany205 participantsStarted 2025-12-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: During surgery (intraoperative)

Ability to complete the procedure as planned, using the device

Timeframe: During surgery

Trial details

NCT IDNCT06799156

SponsorBeaver-Visitec International, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10

Contact for this trial

Siegfried Priglinger, Dr. med.

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

View on ClinicalTrials.gov More Cataract trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.