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

• Sponsor: VISTA Ophthalmics (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05689333
• Collaborator: CBCC Global Research (Other)
• Enrollment: 50
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 4.7
• Patients Per Site: 12.5
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitrectomy	Device: Vista Vitrectomy Probe	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 9, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Incidence of post-operative rates of retinal tears [Month 1]

   Calculate the incidence of post-operative rates of retinal tears

2. Incidence of retinal detachment [Month 1]

   Calculate the incidence of post-operative retinal detachment

3. Incidence of sclerotomy complications like leakage [Month 1]

   Calculate the incidence of post-operative sclerotomy complications like leakage

4. Incidence of ocular hypotony [Month 1]

   Calculate the incidence of post-operative ocular hypotony

5. Incidence of choroidal detachment [Month 1]

   Calculate the incidence of post-operative choroidal detachment

6. 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)

7. Incidence of endophthalmitis [Month 1]

   Calculate the incidence of post-operative endophthalmitis

Secondary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CBCC Global Research Site:003	Los Angeles	California	United States	90067
2	CBCC Global Research Site:002	Bradenton	Florida	United States	34209
3	CBCC Global Research Site:001	Bala-Cynwyd	Pennsylvania	United States	19004
4	CBCC Global Research Site:004	McAllen	Texas	United States	78503

Sponsors and Collaborators

• VISTA Ophthalmics
• CBCC Global Research

Investigators

• Study Chair: Don Knowles, VISTA Ophthalmics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: VISTA Ophthalmics
• ClinicalTrials.gov Identifier: NCT05689333
• Other Study ID Numbers: CBCC/2022/009
• First Posted: Jan 19, 2023
• Last Update Posted: Jan 19, 2023
• Last Verified: Jan 1, 2023

• 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
• Keywords provided by VISTA Ophthalmics: Vitrectomy Probe; Vitreous aspiration & cutting; Dissect tissue in the eye

Study Results

No Results Posted as of Jan 19, 2023