NCT04409808

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2022

Completed
Last Updated

November 16, 2022

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

May 5, 2020

Last Update Submit

November 10, 2022

Conditions

Vitrectomy

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (1)

IRIS vitrectomy device

EXPERIMENTAL

all subjects in this study are in the experimental treatment arm and vitrectomy by use of prototype IRIS vitrectomy device

Device: IRIS

Interventions

IRISDEVICE

prototype IRIS vitrectomy device.

IRIS vitrectomy device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Unable to obtain informed consent from patient (or from parents in children)
  • No post-operative 8 week visit is anticipated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Vlaams Brabant, 3020, Belgium

Location

Study Officials

  • Peter Stalmans, PHd MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

June 1, 2020

Study Start

September 21, 2021

Primary Completion

November 7, 2022

Study Completion

November 7, 2022

Last Updated

November 16, 2022

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)