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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-09

Study Completion Date

2024-05-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitrectomy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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27 GA Vista Ophthalmics vitrector

The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector.

Group Type EXPERIMENTAL

Vista Vitrectomy Probe

Intervention Type DEVICE

Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector

Interventions

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Vista Vitrectomy Probe

Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No