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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-08

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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POAG MIGS

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

cataract operation and istent

Intervention Type PROCEDURE

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.

cataract operation only

Intervention Type PROCEDURE

Patients have a classic postoperative treatment after cataract.

Interventions

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cataract operation and istent

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

Intervention Type PROCEDURE

cataract operation only

Patients have a classic postoperative treatment after cataract.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No