NCT07140692

EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE

VISTA OPHTHALMICS 1-STEP VITRECTOR POST MARKET LIMITED VITREOUS REMOVAL (LVR) CLINICAL ASSESSMENT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The Eye Centers of Racine and Kenosha · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vitreous opacities or floaters are a common ocular condition that can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy involves the surgical removal of vitreous humour, the transparent jelly, from inside the eye that contains vitreous opacities and floaters. The present post-market clinical assessment study aims to assess the safety and effectiveness performance of the Vista 1-Step vitrectomy probe in adult pseudophakic patients with visually symptomatic opacities.

Detailed description

Vitreous opacities or floaters are a common ocular condition that seems ubiquitous in a retina practice. Although symptoms are minimal in most patients, they can cause significant impairment in vision-related quality of life (QoL) in some patients. Vitrectomy is a surgical procedure to remove the vitreous humour, the transparent jelly, from inside the eye. Vitrectomy Surgery can be of two types: Full and Limited. Full Vitrectomy is the commonly used and standard technique for repairing retinal detachments, removing membranes or haemorrhages, and involves vitreous detachment from the retina and its removal, both centrally and peripherally. Limited Vitrectomy is a new technique which focuses on the removal of only the central part of the vitreous or Core with the Vitreous Opacities or "Floaters" in it, and without intentionally detaching it from the retina. The Vista Ophthalmics vitrectomy probe is a single-use vitrector intended to perform anterior/posterior vitrectomy procedures and to remove vitreous and dissect tissue in the eye. The Vista Ophthalmic's probe is designed as a stand-alone handpiece for use with ophthalmic systems.

Conditions

• Vitreous Floaters
• Vitreous Opacities

Interventions

Type	Name	Description
DEVICE	Vitrectomy	In this single-arm, non-comparative study, patients presenting with vitreous opacities affecting daily activities of living will undergo vitrectomy using the single-use vitrector probe of Vista Ophthalmics for the removal of the vitreous opacities.

Timeline

• Start date: 2023-09-14
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2025-08-25
• Last updated: 2025-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study