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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03478293
Enrollment
6
Registered
2018-03-27
Start date
2018-02-27
Completion date
2020-12-30
Last updated
2022-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open Angle Glaucoma (POAG)

Brief 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.

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.

Interventions

DEVICEiStent inject surgery

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

Sponsors

Glaukos Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Single (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
IOP reduction at 12 and 24 months on same number or fewer medications12 months and 24 monthsIOP reduction at 12 and 24 months on same number or fewer medications

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026