GCF-041: A Prospective Evaluation of Glaucoma Subjects Treated With Two Second Generation iStents and One iStent Supra

Sponsor

Glaukos Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03255798

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle	Device: G2 and G3	N/A

Detailed Description

Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

G2 and G3G2 and G3

Masking:

None (Open Label)

Masking Description:

IOP outcome is masked

Primary Purpose:

Treatment

Official Title:

A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects Treated With Two Second Generation Micro-bypass Stents and One Suprachoroidal Stent

Actual Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: G2 and G3 implantation Two iStent inject stents and one iStent Supra stent	Device: G2 and G3 Two iStent inject devices and one iStent supra device

Arm

Intervention/Treatment

Other: G2 and G3 implantation

Two iStent inject stents and one iStent Supra stent

Device: G2 and G3

Two iStent inject devices and one iStent supra device

Outcome Measures

Primary Outcome Measures

20% IOP reduction [Month 12]
IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Secondary Outcome Measures

IOP less than or equal to 18 mm Hg [Month 12]
IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prof. Dr. med. Carl Erb	Berlin		Germany

Sponsors and Collaborators

Glaukos Corporation

Investigators

Study Chair: Kerry Stephens, OD, Glaukos Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT03255798

Other Study ID Numbers:

GCF-041

First Posted:

Aug 21, 2017

Last Update Posted:

Mar 8, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 8, 2019