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

Recruiting

• Conditions: MIGS; POAG
• Interventions: Procedure: cataract operation and istent; Procedure: cataract operation only

• Registration Number: NCT05062668
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-09-30
• Study Start: 2021-10-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
iStent	cataract operation and 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 only	cataract operation only	POAG patients operated only on cataract from January 2018 to September 2020.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Amiens Nord; 🇫🇷 Amiens, France