53
Participants
Start Date
March 31, 2013
Primary Completion Date
November 8, 2019
Study Completion Date
November 8, 2019
Implantation of two iStent inject micro-bypass stents
\- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
Topical travoprost
\- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
Two iStent inject micro-bypass stents
\- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
Tobramycin
"Topical antibiotic (tobramycin):~1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) ."
Dexamethasone
"Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):~* Week 1: 1 drop four (4) times per day in the study eye~* Week 2: 1 drop three (3) times per day in the study eye~* Week 3: 1 drop two (2) times per day in the study eye~* Week 4: 1 drop one (1) time per day in the study eye"
S.V. Malayan's Ophtalmology Centre, Yerevan
Lead Sponsor
Glaukos Corporation
INDUSTRY