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

NCT05689333 | Completed FDA Device

• 1 other identifier: CBCC/2022/009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Vitrectomy

Keywords

Vitrectomy Probe; Vitreous aspiration & cutting; Dissect tissue in the eye

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• Surgeon- will assess device adequacy for removal of vitreous

  Day 0 (Operative Visit)

• Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking

  Days1, 7, 30 & 90

Study Arms (1)

27 GA Vista Ophthalmics vitrector

EXPERIMENTAL

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

Device: Vista Vitrectomy Probe

Interventions

Vista Vitrectomy Probe DEVICE

Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector

27 GA Vista Ophthalmics vitrector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VISTA Ophthalmics: lead
• CBCC Global Research: collaborator

Study Sites (4)

CBCC Global Research Site:003

Los Angeles, California, 90067, United States

Location

CBCC Global Research Site:002

Bradenton, Florida, 34209, United States

Location

CBCC Global Research Site:001

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

CBCC Global Research Site:004

McAllen, Texas, 78503, United States

Location

Study Officials

• Don Knowles

  VISTA Ophthalmics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 19, 2023
• Study Start: December 9, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

US (4)