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

Centre Hospitalier Universitaire, Amiens100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

POAG MIGS

Interventions

cataract operation and istentPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 1 year