Clinical Study to Investigate the Safety and Performance of the Virtuoso Phaco-vitrectomy Device

Launched by BEAVER-VISITEC INTERNATIONAL, INC. · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is looking into the safety and effectiveness of a new device called the Virtuoso Phaco-vitrectomy Device, which is used during eye surgeries for cataracts and vitrectomy (a procedure to remove the gel-like substance in the eye). The goal of the study is to gather information about how well the device works and to hear feedback from users before it can be approved for wider use.

To participate in the trial, individuals must be at least 18 years old and scheduled for a vitrectomy or a combined procedure. They should be able to give their consent to join the study and attend follow-up visits. However, there are certain criteria that may exclude people from participating, such as having specific eye conditions or being pregnant or nursing. If you qualify and decide to join, you can expect to undergo the surgery with the new device and follow-up appointments to monitor your recovery.

Gender

ALL

Eligibility criteria

• 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