Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device (Virtuoso1)

Beaver-Visitec

Status: Not yet enrolling

Conditions: Vitrectomy; Vitrectomy Operation Under General Anesthesia; Cataract

Study type: Observational

Funder types: Industry

Identifiers

NCT06799156

Virtuoso1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

205 participants in 3 patient groups

Cataract subgroup

Description:

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

Description:

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

Description:

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.