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
Verified date | December 2017 |
Source | Glaukos Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Armenia | S.V. Malayan's Ophthalmology Centre | Yerevan |
Lead Sponsor | Collaborator |
---|---|
Glaukos Corporation |
Armenia,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01252888 -
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
|
Phase 4 |