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

Last updated: February 7, 2023
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Open Angle Glaucoma

Glaucoma

Treatment

N/A

Clinical Study ID

NCT05062668
PI2021_843_0191
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • patient who have undergone combined phacoemulsification surgery and insertion of atleast one iStent® for chronic open-angle glaucoma in the ophthalmology department ofthe Amiens University Hospital or the Saint-Quentin University Hospital (iStent®group).
  • patient who have undergone simple phacoemulsification surgery in a patient withchronic open-angle glaucoma in the ophthalmology department of the Amiens UniversityHospital (control group).
  • patient with Chronic open-angle glaucoma confirmed by gonioscopic examination, visualfield, optical coherence tomography of the optic nerve, fundus examination, pachymetryand intraocular air pressure and/or applanation.

Exclusion

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.

Study Design

Total Participants: 100
Study Start date:
October 08, 2021
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • CHU Amiens Nord

    Amiens, 80054
    France

    Active - Recruiting

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