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
Status: Completed
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
CBCC Global Research Site:003
Los Angeles
Florida
CBCC Global Research Site:002
Bradenton
Pennsylvania
CBCC Global Research Site:001
Bala-cynwyd
Texas
CBCC Global Research Site:004
Mcallen
Time Frame
Start Date: 2022-12-09
Completion Date: 2024-05-07
Participants
Target number of participants: 32
Treatments
Experimental: 27 GA Vista Ophthalmics vitrector
The vitrectomy will be performed through the pars plana using the 27 GA Vista Ophthalmics vitrector.
Related Therapeutic Areas
Sponsors
Collaborators: CBCC Global Research
Leads: VISTA Ophthalmics