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TerminatedNCT03478293Updated Sep 9, 2022

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

An interventional study of iStent inject surgery in Primary Open Angle Glaucoma (POAG), sponsored by Glaukos Corporation. Terminated at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-09.

Sponsored by Glaukos Corporation · Not applicable, Interventional, and Treatment

Why this study was terminated
Business Decision
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Primary Open Angle Glaucoma (POAG)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diagnosed with primary open angle glaucoma (POAG)
  • Subject on two ocular hypotensive medications

Exclusion criteria

Exclusion Criteria:

  • Traumatic, uveitic, neovascular, or angle closure glaucoma
  • Fellow eye already enrolled
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    iStent inject surgery

    Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject

    Device: iStent inject surgery

Interventions

  • DeviceiStent inject surgery

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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months and 24 months

06

Study locations

1 site
  • Department of Ophthalmology - UNIFESP/ Hospital São Paulo
    São Paulo, 04023-62, Brazil
07

Registry details

Key details

Study ID
NCT03478293
Lead sponsor
Glaukos Corporation
Responsible party
Sponsor
First posted
Mar 27, 2018
Start date
Feb 27, 2018
Primary completion
Dec 30, 2020
Completion
Dec 30, 2020
Last update
Sep 9, 2022

Study contacts

Kerry Stephens, OD
study director · Glaukos Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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