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

November 10, 2022 updated by: Universitaire Ziekenhuizen KU Leuven

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

to determine the safety and effectiveness of the device.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3020
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IRIS vitrectomy device
all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device
Device: IRIS
prototype IRIS vitrectomy device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of intra-operative adverse events that determine the safety of the surgery
Time Frame: 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
Intraoperative (surgery day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Peter Stalmans, PHd MD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Actual)

November 7, 2022

Study Completion (Actual)

November 7, 2022

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 29, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • S62660

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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