Primary Open Angle Glaucoma
Conditions
Keywords
Primary Open Angle Glaucoma, POAG
Brief summary
The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.
Detailed description
This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens. Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus. Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.
Interventions
DRUGprestudy topical glaucoma medications
Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.
Sponsors
Ivantis, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elevated intraocular pressure (IOP) * Diagnosis of mild to advanced open-angle glaucoma * Shaffer Grade III * Mental capacity to cooperate when undergoing operative and postoperative examination * 18 years of age or older * Provide written informed consent * Willing and able to return to scheduled follow-up examinations for 24-months
Exclusion criteria
* Closed-angle and narrow-angle forms of glaucoma * Secondary glaucomas * Congenital or developmental glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in IOP of study eye between each randomized group | Baseline & One year | Effectiveness will be determined by comparing the IOP at the baseline (pre-operative) visit to the the IOP at the 12 month post-operative visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in glaucoma medications | Baseline & One year | Calculate the change in the number of glaucoma medications from baseline (pre-operative) visit to the 12-month post-operative visit. |
Countries
Austria, Germany, Mexico
Outcome results
None listed