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

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: Recruiting
• Conditions: POAG; MIGS
• Intervention / Treatment: Procedure: cataract operation and istent; Procedure: cataract operation only

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Benjamin Jany, MD; Phone Number: 03 22 08 92 19; Email: jany.benjamin@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens Nord
    • Contact: Benjamin Jany, MD; Phone Number: 03 22 08 92 19; Email: jany.benjamin@chu-amiens.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

2

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	variation of IOP (in mmHg) between the istent and cataract operation group versus the cataract operation only group	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Central Hospital Saint Quentin

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

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): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: POAG; iStent inject; MIGS
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• 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