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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05062668

Acronym

EII

Enrollment

Registered

2021-09-30

Start date

2021-09-20

Completion date

2022-09-20

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MIGS, POAG

Keywords

POAG, iStent inject, MIGS

Brief summary

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.

Interventions

PROCEDUREcataract operation and istent

a cataract operation and the placement of one or two iStent inject or inject W at the same time

PROCEDUREcataract operation only

Patients have a classic postoperative treatment after cataract.

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026