27 GA Vista Ophthalmics vitrector for Vitrectomy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VitrectomyVista Vitrectomy Probe - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Study Objectives

7 Primary · 2 Secondary · Reporting Duration: Month 1

Day 0 (Operative Visit)
Surgeon- will assess device adequacy for removal of vitreous
Days1, 7, 30 & 90
Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking
Month 1
Incidence of choroidal detachment
Incidence of endophthalmitis
Incidence of ocular hypotony
Incidence of post-operative rates of retinal tears
Incidence of retinal detachment
Incidence of sclerotomy complications like leakage
Incidence of visually significant vitreous hemorrhage

Trial Safety

Trial Design

1 Treatment Group

27 GA Vista Ophthalmics vitrector
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: 27 GA Vista Ophthalmics vitrector · No Placebo Group · N/A

27 GA Vista Ophthalmics vitrector
Device
Experimental Group · 1 Intervention: Vista Vitrectomy Probe · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: month 1

Who is running the clinical trial?

VISTA OphthalmicsLead Sponsor
CBCC Global ResearchNETWORK
4 Previous Clinical Trials
1,033 Total Patients Enrolled
Don KnowlesStudy ChairVISTA Ophthalmics

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female adult, aged 18 and above.
You must have a medical need for anterior vitrectomy.
You must be capable of comprehending and providing consent in writing, after being informed regarding the purpose and nature of this study.
Participants must possess the capacity and readiness to adhere to all research protocols.