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

NCT03624699 | Completed DMC FDA Device

• 1 other identifier: GLK-iStent-inject
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glaucoma, Open-Angle

Keywords

glaucoma; Minimally Invasive Glaucoma Surgery

Outcome Measures

Primary Outcomes (1)

• Performance Outcome: IOP reduction

  Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.

  12 months

Secondary Outcomes (2)

• Quality of life: NEI VFQ-25 score

  12 months

• Safety Outcome: Adverse events

  12 months

Study Arms (1)

Glaukos iStent inject®

EXPERIMENTAL

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®

Interventions

Glaukos iStent inject® DEVICE

iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma

Glaukos iStent inject®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Kaweh Mansouri: lead
• Glaukos Corporation: collaborator

Study Sites (1)

Glaucoma Research Centre, Montchoisi Clinic

Lausanne, Canton of Vaud, 1006, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 32433094 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Kaweh Mansouri, MD MPH

  Glaucoma Research Centre, Montchoisi Clinic, Lausanne

  STUDY DIRECTOR

• André Mermoud, MD

  Glaucoma Research Centre, Montchoisi Clinic, Lausanne

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator, Primary investigator

Model Details: Historic control (before vs. after intervention).

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 10, 2018
• Study Start: April 25, 2018
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)