Vitrectomy Clinical Trial
— IRISOfficial title:
IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.
Verified date | September 2021 |
Source | Universitaire Ziekenhuizen KU Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To perform a safety study on the prototype IRIS vitrectomy device.
Status | Terminated |
Enrollment | 39 |
Est. completion date | November 7, 2022 |
Est. primary completion date | November 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of intra-operative adverse events that determine the safety of the surgery | 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 | Intraoperative (surgery day) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04566237 -
Objective Measurements of the Opacification of the Lens After Vitrectomy
|
N/A | |
Completed |
NCT00532415 -
Safety and Efficacy of Vitreous Delineating Agent During Vitrectomy
|
Phase 3 | |
Completed |
NCT04076072 -
Beveled-Tip Versus(vs) Standard-Tip Vitrectomy Probe
|
N/A | |
Not yet recruiting |
NCT03633266 -
Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy
|
N/A | |
Completed |
NCT00927628 -
Macular Hole Reopening
|
N/A | |
Not yet recruiting |
NCT03637283 -
Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
|
N/A | |
Completed |
NCT01255293 -
Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments
|
N/A | |
Terminated |
NCT01023009 -
Postoperative Evolution After Small Gauge Vitrectomy Without Eye Occlusion
|
||
Completed |
NCT00737022 -
Macular Appearance After Diabetic Vitrectomy
|
N/A | |
Completed |
NCT02644694 -
PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy
|
Phase 1 | |
Completed |
NCT03902795 -
Functional and Morphological Results of Rhegmatogenous Retinal Detachment Treated With Vitrectomy
|
||
Completed |
NCT01319318 -
Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy
|
N/A | |
Not yet recruiting |
NCT04346095 -
Oral Sedation in Vitreoretinal Surgery
|
Phase 4 | |
Completed |
NCT01159665 -
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
|
Phase 2 | |
Completed |
NCT00685490 -
Vitrectomy for Branch Retinal Vein Occlusion
|
N/A | |
Completed |
NCT05446948 -
Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy
|
N/A | |
Completed |
NCT05710458 -
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
|
N/A | |
Terminated |
NCT02995746 -
Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane
|
N/A | |
Completed |
NCT03701542 -
The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.
|
||
Completed |
NCT00799227 -
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
|
Phase 2 |