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

Vitrectomy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05689333
• Other study ID #: CBCC/2022/009
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 9, 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: VISTA Ophthalmics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitrectomy

Intervention

Device:
• Vista Vitrectomy Probe
Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector

Locations

Country	Name	City	State
United States	CBCC Global Research Site:001	Bala-Cynwyd	Pennsylvania
United States	CBCC Global Research Site:002	Bradenton	Florida
United States	CBCC Global Research Site:003	Los Angeles	California
United States	CBCC Global Research Site:004	McAllen	Texas

Sponsors (2)

Lead Sponsor	Collaborator
VISTA Ophthalmics	CBCC Global Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative rates of retinal tears	Calculate the incidence of post-operative rates of retinal tears	Month 1
Primary	Incidence of retinal detachment	Calculate the incidence of post-operative retinal detachment	Month 1
Primary	Incidence of sclerotomy complications like leakage	Calculate the incidence of post-operative sclerotomy complications like leakage	Month 1
Primary	Incidence of ocular hypotony	Calculate the incidence of post-operative ocular hypotony	Month 1
Primary	Incidence of choroidal detachment	Calculate the incidence of post-operative choroidal detachment	Month 1
Primary	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
Primary	Incidence of endophthalmitis	Calculate the incidence of post-operative endophthalmitis	Month 1
Secondary	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)
Secondary	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