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

May 4, 2022 updated by: Dr. Kaweh Mansouri

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Performance Outcome: IOP reduction
Time Frame: 12 months
Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life: NEI VFQ-25 score
Time Frame: 12 months
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
Time Frame: 12 months
Rate of adverse events through the follow-up period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dr. Kaweh Mansouri

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Glaukos Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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