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

POAG Clinical Trial

— EII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05062668
• Other study ID #: PI2021_843_0191
• Status: Recruiting
• Start date: October 8, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Benjamin Jany, MD
• Phone: 03 22 08 92 19
• Email: jany.benjamin[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• POAG

Intervention

Procedure:
• cataract operation and istent
a cataract operation and the placement of one or two iStent inject or inject W at the same time
• cataract operation only
Patients have a classic postoperative treatment after cataract.

Locations

Country	Name	City	State
France	CHU Amiens Nord	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Central Hospital Saint Quentin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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