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

NCT05062668 | Unknown

• 1 other identifier: PI2021_843_0191
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

POAG; MIGS

Keywords

POAG; iStent inject; MIGS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

cataract only

POAG patients operated only on cataract from January 2018 to September 2020.

Procedure: cataract operation only

Interventions

cataract operation and istent PROCEDURE

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

iStent

cataract operation only PROCEDURE

Patients have a classic postoperative treatment after cataract.

cataract only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• acute angle closure glaucoma,
• chronic angle closure glaucoma,
• uveitic glaucoma,
• traumatic glaucoma,
• exfoliative glaucoma.
• Previous filtering surgery on the operated eye.
• Intraoperative complication.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Central Hospital Saint Quentin: collaborator

Study Sites (1)

CHU Amiens Nord

Amiens, 80054, France

RECRUITING

Central Study Contacts

Benjamin Jany, MD

CONTACT

03 22 08 92 19; jany.benjamin@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: October 8, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)