IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.
Not Applicable
Terminated
- Conditions
- Vitrectomy
- Interventions
- Device: IRIS
- Registration Number
- NCT04409808
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief Summary
To perform a safety study on the prototype IRIS vitrectomy device.
- Detailed Description
to determine the safety and effectiveness of the device.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IRIS vitrectomy device IRIS all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium