NCT06799156

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 205 (estimated)
• Sponsor: Beaver-Visitec International, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cataract
• Vitrectomy
• Vitrectomy Operation Under General Anesthesia

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-10-01
• Completion: 2026-11-01
• First posted: 2025-01-29
• Last updated: 2025-11-21