Vitrectomy
Conditions
Brief summary
To perform a safety study on the prototype IRIS vitrectomy device.
Detailed description
to determine the safety and effectiveness of the device.
Interventions
DEVICEIRIS
prototype IRIS vitrectomy device.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients that are scheduled for vitrectomy surgery, regardless of the indication * Both vitrectomy-only and combined phaco-vitrectomy surgeries * Primary or repeat vitrectomy * General or local anesthesia, or combination * All ages * Informed consent (from parents in patients \<18 years old)
Exclusion criteria
* Unable to obtain informed consent from patient (or from parents in children) * No post-operative 8 week visit is anticipated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of intra-operative adverse events that determine the safety of the surgery | Intraoperative (surgery day) | complications VTX: iatrogenic tear, lens touch, choroidal/subretinal/vitreous hemorrhage, infusion suprachoroidal, iatrogenic retina trauma, posterior capsule tear, corneal eptihelial damage, hyphema, corneal edema, iris trauma, nucleus fragment in vitreous, posterior capsule tear, retinal incarceration, zonulae rupture with vitreous prolapse, subretinal PFCL, suprachoroidal silicone oil, zonulae dialysis, lens exchange required, other IOL problem |
Countries
Belgium
Outcome results
None listed