CataractVitrectomyVitrectomy Operation Under General Anesthesia
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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