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

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ClinicalTrials.gov Identifier: NCT03624699
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Collaborator:
Glaukos Corporation
Information provided by (Responsible Party):
dr. Kaweh Mansouri, Swiss Vision Network

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Device: Glaukos iStent inject® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Historic control (before vs. after intervention).
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020


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




Primary Outcome Measures :
  1. Performance Outcome: IOP reduction [ Time Frame: 12 months ]
    Proportion of patients with IOP reduction of ≥ 20% vs. baseline mean IOP, at 12 months.


Secondary Outcome Measures :
  1. 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.

  2. Safety Outcome: Adverse events [ Time Frame: 12 months ]
    Rate of adverse events through the follow-up period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624699


Contacts
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Contact: Kaweh Mansouri, MD MPH 021 619 37 42 ext +41 kmansouri@gsvn.ch
Contact: André Mermoud, MD 021 619 37 42 ext +41 amermoud@gsvn.ch

Locations
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Switzerland
Glaucoma Research Centre, Montchoisi Clinic Recruiting
Lausanne, VD, Switzerland, 1006
Contact: Kaweh Mansouri, MD MPH    021 619 37 42 ext +41    kmansouri@gsvn.ch   
Contact: André Mermoud, MD    021 619 37 42 ext +41    amermoud@gsvn.ch   
Principal Investigator: Kaweh Mansouri, MD MPH         
Principal Investigator: André Mermoud, MD         
Principal Investigator: Kevin Gillmann, MBBS MArch         
Sponsors and Collaborators
dr. Kaweh Mansouri
Glaukos Corporation
Investigators
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Study Director: Kaweh Mansouri, MD MPH Glaucoma Research Centre, Montchoisi Clinic, Lausanne
Study Director: André Mermoud, MD Glaucoma Research Centre, Montchoisi Clinic, Lausanne

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Responsible Party: dr. Kaweh Mansouri, Sponsor-Investigator, Primary investigator, Swiss Vision Network
ClinicalTrials.gov Identifier: NCT03624699     History of Changes
Other Study ID Numbers: GLK-iStent-inject
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by dr. Kaweh Mansouri, Swiss Vision Network:
glaucoma
Minimally Invasive Glaucoma Surgery

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases