Vitrectomy
Conditions
Keywords
Vitrectomy Probe, Vitreous aspiration & cutting, Dissect tissue in the eye
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.
Interventions
DEVICEVista Vitrectomy Probe
Vitrectomy will be performed through 27 GA Vista Ophthalmics vitrector
Sponsors
CBCC Global Research
VISTA Ophthalmics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-operative rates of retinal tears | Month 1 | Calculate the incidence of post-operative rates of retinal tears |
| Incidence of choroidal detachment | Month 1 | Calculate the incidence of post-operative choroidal detachment |
| 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 retinal detachment | Month 1 | Calculate the incidence of post-operative retinal detachment |
| 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 |
| Incidence of ocular hypotony | Month 1 | Calculate the incidence of post-operative ocular hypotony |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed