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

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.

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.

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