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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Vitrectomy
• Intervention / Treatment: Device: Vista Vitrectomy Probe

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eldho Jose; Email: eldho.jose@cbcc.global

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90067
      • CBCC Global Research Site:003
  • Florida
    • Bradenton, Florida, United States, 34209
      • CBCC Global Research Site:002
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • CBCC Global Research Site:001
  • Texas
    • McAllen, Texas, United States, 78503
      • CBCC Global Research Site:004

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 27 GA Vista Ophthalmics vitrector; The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector.	Device: Vista Vitrectomy Probe; Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VISTA Ophthalmics
• Collaborators: CBCC Global Research
• Investigators: Study Chair: Don Knowles, VISTA Ophthalmics

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Vitrectomy Probe; Vitreous aspiration & cutting; Dissect tissue in the eye
• Other Study ID Numbers: CBCC/2022/009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes