Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Implantation of two iStent inject devices
Travoprost drops
S.V. Malayan Ophthalmological Center
Yerevan, Armenia
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
Time frame: 12 months
Change in mean diurnal IOP vs. screening
Time frame: Month 24
Change in screening in time-wise IOPs
Time frame: Various Month 12-60
Proportion of responders
A responder is defined as a subject with a certain target IOP value or a certain reduction of IOP as compared to screening. In the iStent inject group, a responder must not be on an ocular hypotensive medications or have had a postoperative procedure to reposition or remove stent(s) prior to the visit. Due to the lack of a complete consensus on the definition of a clinical responder, a set of target IOP values (e.g., downwards from 22 mm Hg in steps of 1 mm Hg) and reductions of IOP (e.g., downwards from the highest reduction in IOP in steps of 5%) will be evaluated.
Time frame: Various 12-60 months
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