Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
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.
Outcomes
Primary Outcomes
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.
Time Frame: During surgery (intraoperative)
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.
Ability to complete the procedure as planned, using the device
Time Frame: During surgery
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.
Secondary Outcomes
- 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))
- 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))
- 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))
- To evaluate user satisfaction with the device - sutureless procedure(During surgery (intraoperative))
- To evaluate user satisfaction with the device - success rate(During surgery (intraoperative))
- To evaluate user satisfaction with the device - procedure time(During surgery (intraoperative))
- To evaluate user satisfaction with the device - fluid volume(During surgery (intraoperative))
- To evaluate user satisfaction with the device - Aspiration(During surgery (intraoperative))
- To evaluate user satisfaction with the device - sutureless vitrectomy(During surgery (intraoperative))