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NCT04409808 Clinical Trial

IRIS Alfa Clinical Trial A Monocentric, Academic Clinical Trial Safety Study of a Prototype of a New Vitrectomy Device.

Vitrectomy Clinical Trial

— IRIS  

Official title:
IRIS Alfa Clinical Trial. A Safety Study of a Prototype of a New Vitrectomy Device.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04409808
Other study ID # S62660
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 21, 2021
Est. completion date November 7, 2022

Study information
Verified date September 2021
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To perform a safety study on the prototype IRIS vitrectomy device.

Description:

to determine the safety and effectiveness of the device.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• IRIS
prototype IRIS vitrectomy device.

Locations
Country Name City State
Belgium UZ Leuven Leuven Vlaams Brabant

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
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)
See also
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Completed NCT05446948 - Observation of the Efficacy of Different Vitrectomy Systems to Treat Proliferative Diabetic Retinopathy N/A
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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