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.
Study Type
OBSERVATIONAL
Enrollment
205
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.
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.
Time frame: During surgery (intraoperative)
Ability to complete the procedure as planned, using the device
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.
Time frame: During surgery
Rate of postoperative Adverse Events (AEs)
The rate of Adverse Events (AEs) intra-operatively, defined as the percentage of procedures with at least one identified AE (numerator) out of the total procedures performed (denominator), measured as a percentage (%).
Time frame: From 1 day after surgery to the end of enrollment at 90 days postoperatively
To evaluate the performance of the device
Rate of Device Deficiencies (DDs) intra-operatively: The rate of Device Deficiencies (DDs) intra-operatively, defined as the percentage of procedures with at least one identified device deficiency (numerator) out of the total procedures performed (denominator), measured as a percentage (%).
Siegfried Priglinger, Univ. Prof. Dr. med.
CONTACT
Maximilian-Joachim Gerhardt, Dr.med.
CONTACT
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Time frame: During surgery (intraoperative)
To evaluate the possible reduction of total surgical time
Collection of procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- Rate of sutureless cataract procedure (cataract and combined subgroups)
Time frame: 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
* Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge * List of all other medical devices used during the procedure
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- Success rate of intended surgical procedures
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- Procedure time(s) for subgroups cataract, vitrectomy and combined procedure)
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure)
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- List of all other medical devices used during the procedure
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- Evaluation of the learning curve for surgeons using the new system: ADE and Aspiration time, Total Procedure Time for subgroups cataract, vitrectomy and combined procedure
Time frame: During surgery (intraoperative)
To evaluate user satisfaction with the device
\- Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge):
Time frame: During surgery (intraoperative)