Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

Subjects With Primary Open-angle Glaucoma (POAG) Clinical Trial

Official title:

A Prospective Evaluation of Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252862
• Other study ID #: GCF-017
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2010
• Last updated: December 14, 2017
• Start date: December 2010
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Glaukos Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

Description:

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with primary open-angle glaucoma (POAG)

• Subject on one topical hypotensive medication

Exclusion Criteria:

• Traumatic, uveitic, neovascular, or angle closure glaucoma

• Fellow eye already enrolled

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Subjects With Primary Open-angle Glaucoma (POAG)

Intervention

Device:
• iStent
Implantation of two iStents through a small temporal clear corneal incision

Locations

Country	Name	City	State
Armenia	S.V. Malayan's Ophthalmology Centre	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

References & Publications (1)

Donnenfeld ED, Solomon KD, Voskanyan L, Chang DF, Samuelson TW, Ahmed II, Katz LJ. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma. Clin Ophthalmol. 2015 Nov 3;9:2057-65. doi: 10.2147/OPTH.S91732. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs baseline		12 Months
Secondary	IOP < 18 mm Hg at Month 12		12 months