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

VISTA Ophthalmics

Status

Completed

Conditions

Vitrectomy

Treatments

Device: Vista Vitrectomy Probe

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT05689333

CBCC/2022/009

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.