Clinical trial NCT05689333: A Study to Evaluate the Safety and Performance of the Vista Probe for Vitrectomy Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitrectomy
Keywords: Vitrectomy Probe
Vitreous aspiration & cutting
Dissect tissue in the eye
Lead sponsor: VISTA Ophthalmics
Sponsor class: INDUSTRY
Collaborators: name: CBCC Global Research
First posted: 2023-01-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of post-operative rates of retinal tears
timeFrame: Month 1
measure: Incidence of retinal detachment
timeFrame: Month 1
measure: Incidence of sclerotomy complications like leakage
timeFrame: Month 1
measure: Incidence of ocular hypotony
timeFrame: Month 1
measure: Incidence of choroidal detachment
timeFrame: Month 1
measure: Incidence of visually significant vitreous hemorrhage
timeFrame: Month 1
measure: Incidence of endophthalmitis
timeFrame: Month 1
Secondary outcomes:
measure: Surgeon- will assess device adequacy for removal of vitreous
timeFrame: Day 0 (Operative Visit)
measure: Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking
timeFrame: Days1, 7, 30 & 90
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: CBCC Global Research Site:003
state: California
city: Bradenton
country: United States
facility: CBCC Global Research Site:002
state: Florida
city: Bala-Cynwyd
country: United States
facility: CBCC Global Research Site:001
state: Pennsylvania
city: McAllen
country: United States
facility: CBCC Global Research Site:004
state: Texas
Study officials:
affiliation: VISTA Ophthalmics
name: Don Knowles
role: STUDY_CHAIR
References: