NCT03255798

Brief Summary

Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

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

August 1, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

1.8 years

First QC Date

August 17, 2017

Last Update Submit

September 6, 2022

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (1)

  • 20% IOP reduction

    IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg

    Month 12

Secondary Outcomes (1)

  • IOP less than or equal to 18 mm Hg

    Month 12

Study Arms (1)

G2 and G3 implantation

OTHER

Two iStent inject stents and one iStent Supra stent

Device: G2 and G3

Interventions

G2 and G3DEVICE

Two iStent inject devices and one iStent supra device

G2 and G3 implantation

Eligibility Criteria

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

You may qualify if:

  • Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg

You may not qualify if:

  • Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. med. Carl Erb

Berlin, Germany

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Kerry Stephens, OD

    Glaukos Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
IOP outcome is masked
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: G2 and G3
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2017

First Posted

August 21, 2017

Study Start

August 1, 2017

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)