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NCT03478293 Clinical Trial

iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications

Primary Open Angle Glaucoma (POAG) Clinical Trial

Official title:
A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03478293
Other study ID # GCF-045
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 27, 2018
Est. completion date December 30, 2020

Study information
Verified date September 2022
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.

Description:

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.

Recruitment information / eligibility
Status Terminated
Enrollment 6
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with primary open angle glaucoma (POAG) - Subject on two ocular hypotensive medications Exclusion Criteria: - Traumatic, uveitic, neovascular, or angle closure glaucoma - Fellow eye already enrolled

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• iStent inject surgery
Micro-invasive glaucoma surgery (MIGS) to implant iStent inject

Locations
Country Name City State
Brazil Department of Ophthalmology - UNIFESP/ Hospital São Paulo São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary IOP reduction at 12 and 24 months on same number or fewer medications IOP reduction at 12 and 24 months on same number or fewer medications 12 months and 24 months
See also
  Status Clinical Trial Phase
Completed NCT01085357 - Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery N/A
Completed NCT02434692 - Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG) N/A
Completed NCT02700984 - A Study to Assess Long-Term Safety of the CyPass Micro-Stent in Patients Completing the COMPASS Trial N/A
Recruiting NCT06016972 - Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients Phase 2
Completed NCT01517477 - One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects N/A
Terminated NCT01180062 - Safety Study of Latanoprost Slow Release Insert Phase 1
Completed NCT01166659 - Study of CyPass Implantation In Patients With Open Angle Glaucoma Refractory to Single or Multi-agent Topical Therapy N/A
Completed NCT01252849 - Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects N/A
Active, not recruiting NCT00902109 - Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients N/A