Investigation of the iStent Inject® Devices in Open-Angle Glaucoma

A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma

The aim of this study is to evaluate the safety and intraocular pressure (IOP) lowering effect of two iStent inject devices in combination with cataract surgery in patients with mild-to-moderate open-angle glaucoma.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Glaukos iStent inject®

Detailed Description

Patients suffering from open-angle glaucoma who are planning to undergo cataract surgery and are matching the inclusion criteria will be offered to join the study until the desired sample size (50) is reached. Combined cataract-iStent surgery will be performed as per the devices' manufacturers' instructions. Two iStent inject devices will be micro-invasively implanted in the trabecular meshwork of the eye during planned cataract surgery. Six post-operative follow-ups will be carried out over a duration of 12 months, during which various measurements will be made. Performance Outcomes will analyse the proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 6 and 12 months. Quality of life outcome will look at the improvement in perceived quality of life as expressed in the NEI VFQ-25 questionnaires from baseline to 3 and 12 months. The rate of adverse events will be recorded.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • VD
    • Lausanne, VD, Switzerland, 1006
      • Glaucoma Research Centre, Montchoisi Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma
• Mild to moderate glaucoma (defined as C/D ratio ≤ 0.8)
• Phakic eye requiring cataract surgery
• Preoperative IOP up to 30 mmHg (medicated or not)
• Patients with side-effects to, or complications from, medications
• Patients who would benefit from a reduction of IOP and/or reduction of medication
• Normal angle anatomy as determined by gonioscopy;
• Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair proper placement of iStent inject device
• Able and willing to attend scheduled follow-up exams for 12 months postoperatively
• Able and willing to provide written informed consent on the approved Informed Consent Form

Exclusion Criteria:

• Inclusion of the fellow eye in this study (only one eye per subject)
• Aphakic patients or pseudophakic patients
• Prior stent implantations in the study eye
• Eyes with primary angle closure glaucoma, or any secondary angle closure glaucoma
• Traumatic or uveitic glaucoma; or any glaucoma associated with vascular disorders
• Patients with any type of condition that may cause elevated episcleral venous pressure
• Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma
• Prior glaucoma treatment (laser or surgery)
• Any active corneal inflammation, edema, or opacity severe-enough to impair gonioscopy / fundus examination

• Any pathology for which, in the investigator's judgment, the following would be either at risk or contraindicated:

  • stent implantation,
  • compliance to elements of the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glaukos iStent inject®; Patients suffering from cataract and open-angle glaucoma. Glaukos iStent inject® is implanted during routine cataract surgery. The effect on IOP/glaucoma medications is monitored.	Device: Glaukos iStent inject®; iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance Outcome: IOP reduction	Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life: NEI VFQ-25 score	Improvement in perceived quality of life as expressed in the NEI VFQ-25 (National Eye Institute Vision Function) questionnaires from baseline to 12 months.	12 months
Safety Outcome: Adverse events	Rate of adverse events through the follow-up period.	12 months

Collaborators and Investigators

• Sponsor: Dr. Kaweh Mansouri
• Collaborators: Glaukos Corporation
• Investigators: Study Director: Kaweh Mansouri, MD MPH, Glaucoma Research Centre, Montchoisi Clinic, Lausanne; Study Director: André Mermoud, MD, Glaucoma Research Centre, Montchoisi Clinic, Lausanne

Publications and helpful links

General Publications

• Gillmann K, Mansouri K, Ambresin A, Bravetti GE, Mermoud A. A Prospective Analysis of iStent Inject Microstent Implantation: Surgical Outcomes, Endothelial Cell Density, and Device Position at 12 Months. J Glaucoma. 2020 Aug;29(8):639-647. doi: 10.1097/IJG.0000000000001546.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: glaucoma; Minimally Invasive Glaucoma Surgery
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: GLK-iStent-inject

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes