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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens Nord
RECRUITING
Amiens
Contact Information
Primary
Benjamin Jany, MD
jany.benjamin@chu-amiens.fr
03 22 08 92 19
Time Frame
Start Date: 2021-09-20
Estimated Completion Date: 2026-06
Participants
Target number of participants: 100
Treatments
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
POAG patients operated only on cataract from January 2018 to September 2020.
Sponsors
Collaborators: Central Hospital Saint Quentin
Leads: Centre Hospitalier Universitaire, Amiens

This content was sourced from clinicaltrials.gov