Efficacy and Safety of iStent Inject and Inject W in the Management of Primary Open-angle Glaucoma (EII)

June 23, 2026 updated by: Centre Hospitalier Universitaire, Amiens
Primary open-angle glaucoma (POAG) is a chronic eye disease in which the only validated treatment is to lower intraocular pressure (IOP). It is the 2nd leading cause of blindness worldwide. The iStent® inject and inject W is an implantable device that is part of a new entity of so-called minimally invasive glaucoma surgery whose goal is to lower IOP with minimal tissue disruption in order to avoid the complications of conventional glaucoma surgery. This surgery is used in conjunction with cataract surgery in France. The primary objective is to study the 1-year efficacy and safety of combined cataract and iStent inject and inject W in the management of POAG in an observational, retrospective, controlled study of a cohort of POAG patients undergoing cataract surgery only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

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

  • France
      • Amiens, France, 80054
        • CHU Amiens Nord

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

Sampling Method

Non-Probability Sample

Study Population

There are two groups, the first group is the iStent group. The investigators took all the POAG patients operated at the CHU of Amiens or the CH of Saint-Quentin of a combined cataract and iStent inject or inject W surgery from January 2018 to September 2020. The second group is the control group of POAG patients operated only on cataract during the same period.

Description

Inclusion Criteria:

  • patient who have undergone combined phacoemulsification surgery and insertion of at least one iStent® for chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital or the Saint-Quentin University Hospital (iStent® group).
  • patient who have undergone simple phacoemulsification surgery in a patient with chronic open-angle glaucoma in the ophthalmology department of the Amiens University Hospital (control group).
  • patient with Chronic open-angle glaucoma confirmed by gonioscopic examination, visual field, optical coherence tomography of the optic nerve, fundus examination, pachymetry and intraocular air pressure and/or applanation.

Exclusion Criteria:

  • acute angle closure glaucoma,
  • chronic angle closure glaucoma,
  • uveitic glaucoma,
  • traumatic glaucoma,
  • exfoliative glaucoma.
  • Previous filtering surgery on the operated eye.
  • Intraoperative complication.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
iStent
POAG patient operated at the CHU of Amiens or the CH of Saint-Quentin of a combined cataract and iStent inject or inject W surgery from January 2018 to September 2020.
Procedure: cataract operation and istent
a cataract operation and the placement of one or two iStent inject or inject W at the same time
cataract only
POAG patients operated only on cataract from January 2018 to September 2020.
Procedure: cataract operation only
Patients have a classic postoperative treatment after cataract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
variation of IOP (in mmHg) between both groups
Time Frame: 1 year
variation of IOP (in mmHg) between the istent and cataract operation group versus the cataract operation only group
1 year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Central Hospital Saint Quentin

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 20, 2021

Primary Completion (Actual)

September 20, 2022

Study Completion (Actual)

September 20, 2022

Study Registration Dates

First Submitted

September 21, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

September 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021_843_0191

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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