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

Not Applicable

Completed

• Conditions: Vitrectomy

• Registration Number: NCT05689333
• Lead Sponsor: VISTA Ophthalmics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-16
• Study First Posted: 2023-01-19
• Primary Completion: 2024-05-07
• Study Completion: 2024-05-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of visually significant vitreous hemorrhage	Month 1	Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)
Incidence of choroidal detachment	Month 1	Calculate the incidence of post-operative choroidal detachment
Incidence of post-operative rates of retinal tears	Month 1	Calculate the incidence of post-operative rates of retinal tears
Incidence of retinal detachment	Month 1	Calculate the incidence of post-operative retinal detachment
Incidence of ocular hypotony	Month 1	Calculate the incidence of post-operative ocular hypotony
Incidence of endophthalmitis	Month 1	Calculate the incidence of post-operative endophthalmitis
Incidence of sclerotomy complications like leakage	Month 1	Calculate the incidence of post-operative sclerotomy complications like leakage

Secondary Outcome Measures

Name	Time	Method
Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking	Days1, 7, 30 & 90	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
Surgeon- will assess device adequacy for removal of vitreous	Day 0 (Operative Visit)	Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages

Trial Locations

Locations (4)

CBCC Global Research Site:003; 🇺🇸 Los Angeles, California, United States

CBCC Global Research Site:002; 🇺🇸 Bradenton, Florida, United States

CBCC Global Research Site:001; 🇺🇸 Bala-Cynwyd, Pennsylvania, United States

CBCC Global Research Site:004; 🇺🇸 McAllen, Texas, United States