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

Study Overview
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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.

Official Title
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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

Conditions
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Vitrectomy

Intervention / Treatment
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* Device: Vista Vitrectomy Probe


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 27 GA Vista Ophthalmics vitrector<br>The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector. | Device: Vista Vitrectomy Probe<br>* Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post-operative rates of retinal tears | Calculate the incidence of post-operative rates of retinal tears | Month 1 | 
| Incidence of retinal detachment | Calculate the incidence of post-operative retinal detachment | Month 1 | 
| Incidence of sclerotomy complications like leakage | Calculate the incidence of post-operative sclerotomy complications like leakage | Month 1 | 
| Incidence of ocular hypotony | Calculate the incidence of post-operative ocular hypotony | Month 1 | 
| Incidence of choroidal detachment | Calculate the incidence of post-operative choroidal detachment | Month 1 | 
| Incidence of visually significant vitreous hemorrhage | Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse) | Month 1 | 
| Incidence of endophthalmitis | Calculate the incidence of post-operative endophthalmitis | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon- will assess device adequacy for removal of vitreous | Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages | Day 0 (Operative Visit) | 
| Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking | Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking, at any post-operative visit will be summarized using counts and percentages | Days1, 7, 30 & 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitrectomy Probe, Vitreous aspiration & cutting, Dissect tissue in the eye