EFFECTIVENESS AND SAFETY ASSESSMENT OF THE VISTA VITRECTOMY PROBE

Completed · Not applicable

Conditions studied: Vitreous Floaters, Vitreous Opacities

In brief

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.

Key facts

Study ID

NCT07140692

Run by

The Eye Centers of Racine and Kenosha

People needed

40

Starts

2023-09-14

Expected to finish

2024-07-01

Last updated by the study team

2025-08-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participant with age ≥ 18 years at the time of screening.
• Subjects with Posterior chamber Intraocular lens (PCIOL) in one or both the eyes (both eyes will be independently assessed).
• Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
• Subjects must be willing and able to comply with all treatment and follow-up study procedures.
• Complaints of decreased vision/decreased quality of vision due to vitreous floaters which is having an impact on Activities of daily living (ADLs).
• Documentation of vitreous opacities on Slit lamp exam/Dilated Fundus Exam (SLE/DFE).
• Documentation of decreased DLI on iTrace.

You may not qualify if…

• Subjects with history of retinal tear/detachment, macular edema, Epi-retinal membrane (ERM), vitreomacular traction syndrome (VMT), Age-related macular degeneration (AMD), Proliferative Diabetic Retinopathy (PDR), or other significant retinal disorders in procedural eye.
• Subjects with History of trauma to operative eye.
• Subjects with bleeding disorders or anticoagulation.
• Subjects with history of ocular herpetic infections.
• Female subjects of child bearing potential with positive urine pregnancy test.
• Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.
• Any medical condition that would be contraindicated for cataract surgery.

Where it is running

• The Eye Centers of Racine & Kenosha — Kenosha, Wisconsin, United States

Full record on ClinicalTrials.gov

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