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

Primary Purpose

Glaucoma, Open-Angle

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Glaukos iStent inject®
Sponsored by
Dr. Kaweh Mansouri
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring glaucoma, Minimally Invasive Glaucoma Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Glaucoma Research Centre, Montchoisi Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glaukos iStent inject®

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Safety Outcome: Adverse events
Rate of adverse events through the follow-up period.

Full Information

First Posted
August 7, 2018
Last Updated
May 4, 2022
Sponsor
Dr. Kaweh Mansouri
Collaborators
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03624699
Brief Title
Investigation of the iStent Inject® Devices in Open-Angle Glaucoma
Official Title
A Prospective, Unmasked, Single-Site Investigation of the iStent Inject® Devices Implanted in Combination With Cataract Surgery in Patients With Open-Angle Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Kaweh Mansouri
Collaborators
Glaukos Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
glaucoma, Minimally Invasive Glaucoma Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Historic control (before vs. after intervention).
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaukos iStent inject®
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Glaukos iStent inject®
Intervention Description
iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma
Primary Outcome Measure Information:
Title
Performance Outcome: IOP reduction
Description
Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life: NEI VFQ-25 score
Description
Improvement in perceived quality of life as expressed in the NEI VFQ-25 (National Eye Institute Vision Function) questionnaires from baseline to 12 months.
Time Frame
12 months
Title
Safety Outcome: Adverse events
Description
Rate of adverse events through the follow-up period.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaweh Mansouri, MD MPH
Organizational Affiliation
Glaucoma Research Centre, Montchoisi Clinic, Lausanne
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
André Mermoud, MD
Organizational Affiliation
Glaucoma Research Centre, Montchoisi Clinic, Lausanne
Official's Role
Study Director
Facility Information:
Facility Name
Glaucoma Research Centre, Montchoisi Clinic
City
Lausanne
State/Province
VD
ZIP/Postal Code
1006
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32433094
Citation
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.
Results Reference
derived

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

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