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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252888
• Other study ID #: GCF-018
• Status: Completed
• Phase: Phase 4
• 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 assess efficacy and safety of two iStents for the reduction of intraocular pressure associated 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: 39
• 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)
• Subjects on two topical hypotensive medications

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Armenia, 

References & Publications (2)

Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, Samuelson TW. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014 Aug;40(8):1295-300. doi: 10.1016/j.jcrs.2014.07.004. — View Citation

Chang DF, Donnenfeld ED, Katz LJ, Voskanyan L, Ahmed II, Samuelson TW, Giamporcaro JE, Hornbeak DM, Solomon KD. Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up. Clin Ophthalmol. 2017 Mar 15;11:523-528. doi: 10.2147/OPTH.S121041. eCollection 2017. — 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	Mean diurnal IOP < 18 mmHg at month 12		12 months