NCT03478293

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

2.8 years

First QC Date

March 20, 2018

Last Update Submit

September 6, 2022

Conditions

Primary Open Angle Glaucoma (POAG)

Outcome Measures

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

    12 months and 24 months

Study Arms (1)

iStent inject surgery

EXPERIMENTAL

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

Device: iStent inject surgery

Interventions

iStent inject surgeryDEVICE

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

iStent inject surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology - UNIFESP/ Hospital São Paulo

São Paulo, 04023-62, Brazil

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Kerry Stephens, OD

    Glaukos Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 27, 2018

Study Start

February 27, 2018

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

September 9, 2022

Record last verified: 2022-09

Locations

BR(1)