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OpenTrials
Completed

NCT Number: NCT05062668

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

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.

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Key information

Conditions

POAG MIGS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens Nord

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cataract operation and istent

Procedure

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

cataract operation only

Procedure

Patients have a classic postoperative treatment after cataract.

Primary outcomes

  1. variation of IOP (in mmHg) between both groups

    Time frame: 1 year

    variation of IOP (in mmHg) between the istent and cataract operation group versus the cataract operation only group

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Central Hospital Saint Quentin

Registry information

Acronym: EII

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 30, 2021
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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