Cataract, Vitrectomy, Vitrectomy Operation Under General Anesthesia
Conditions
Keywords
vitrectomy device, vitrectomy, vitrectomy surgery, cataract surgery
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.
Interventions
None listed
Sponsors
Beaver-Visitec International, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to complete the procedure as planned, using the device | 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. |
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate user satisfaction with the device - procedure time | During surgery (intraoperative) | \- Procedure time(s) for subgroups cataract, vitrectomy and combined procedure) |
| To evaluate user satisfaction with the device - fluid volume | During surgery (intraoperative) | \- Fluid volume used (measured in ml) for subgroups cataract, vitrectomy and combined procedure) |
| To evaluate user satisfaction with the device | During surgery (intraoperative) | \- List of all other medical devices used during the procedure |
| To evaluate user satisfaction with the device - Aspiration | During surgery (intraoperative) | \- 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 |
| To evaluate user satisfaction with the device - sutureless vitrectomy | During surgery (intraoperative) | \- Rate of sutureless pars plana vitrectomy (vitrectomy and combined sub-groups, by gauge): |
| To evaluate user satisfaction with the device - sutureless procedure | During surgery (intraoperative) | \- Rate of sutureless cataract procedure (cataract and combined subgroups) |
| Rate of postoperative Adverse Events (AEs) | From 1 day after surgery to the end of enrollment at 90 days postoperatively | 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 (%). |
| To evaluate the performance of the device | During surgery (intraoperative) | 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 (%). |
| 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) | * 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 |
| To evaluate the possible reduction of total surgical time | During surgery (intraoperative) | Collection of procedure time(s) for subgroups cataract, vitrectomy and combined procedure) - for vitrectomy and combined subgroups by Gauge |
| To evaluate user satisfaction with the device - success rate | During surgery (intraoperative) | \- Success rate of intended surgical procedures |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORSiegfried Priglinger, Dr. med.
LMU Munich
STUDY_CHAIRMaximilian-Joachim maximilian.gerhardt@med.uni-muenchen.de, Dr.med.
LMU Munich
Outcome results
None listed