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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector
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
Incidence of post-operative rates of retinal tears
Calculate the incidence of post-operative rates of retinal tears
Time frame: Month 1
Incidence of retinal detachment
Calculate the incidence of post-operative retinal detachment
Time frame: Month 1
Incidence of sclerotomy complications like leakage
Calculate the incidence of post-operative sclerotomy complications like leakage
Time frame: Month 1
Incidence of ocular hypotony
Calculate the incidence of post-operative ocular hypotony
Time frame: Month 1
Incidence of choroidal detachment
Calculate the incidence of post-operative choroidal detachment
Time frame: Month 1
Incidence of visually significant vitreous hemorrhage
Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)
Time frame: Month 1
Incidence of endophthalmitis
Calculate the incidence of post-operative endophthalmitis
Time frame: Month 1
Surgeon- will assess device adequacy for removal of vitreous
Surgeon-assess device adequacy for removal of vitreous will be summarized using counts and percentages
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0 (Operative Visit)
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
Time frame: Days1, 7, 30 & 90