NCT05062668

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	cataract operation and istent	a cataract operation and the placement of one or two iStent inject or inject W at the same time
PROCEDURE	cataract operation only	Patients have a classic postoperative treatment after cataract.

Timeline

• Start date: 2021-10-08
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2021-09-30
• Last updated: 2023-02-08

Locations

1 site across 1 country: France