A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery

Completed · Not applicable

Conditions studied: Vitrectomy

In brief

This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.

Key facts

Study ID

NCT05689333

Run by

VISTA Ophthalmics

People needed

32

Starts

2022-12-09

Expected to finish

2024-05-07

Last updated by the study team

2025-04-01

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.
• Subject must have a clinical indication for anterior vitrectomy.
• 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.

You may not qualify if…

• Subjects who have experienced any significant trauma in the operative eye within the past month.
• Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
• Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP>30mm Hg) in study eye.
• Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
• 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.

Where it is running

• CBCC Global Research Site:003 — Los Angeles, California, United States
• CBCC Global Research Site:002 — Bradenton, Florida, United States
• CBCC Global Research Site:001 — Bala-Cynwyd, Pennsylvania, United States
• CBCC Global Research Site:004 — McAllen, Texas, United States

Full record on ClinicalTrials.gov

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