Glaucoma, Open-Angle
Conditions
Brief summary
Prospective Evaluation of Open-Angle Glaucoma Subjects treated with two second generation iStents and one iStent Supra
Detailed description
Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects treated with Two Second Generation Microbypass Stents and One Suprachoroidal Stent
Interventions
DEVICEG2 and G3
Two iStent inject devices and one iStent supra device
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
IOP outcome is masked
Intervention model description
G2 and G3
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Phakic or pseudophakic subjects with posterior chamber IOLs Primary open-angle glaucoma or pseudoexfoliative glaucoma diagnosis Subject on two ocular hypotensive medications Medicated screening IOP greater than or equal to 18 mm Hg and less than or equal to 30 mm Hg Visual field or optic nerve defect characteristic of glaucoma Normal iridocorneal angle anatomy Absence of peripheral anterior synechiae Mean diurnal IOP at baseline between 21 and 45 mm Hg
Exclusion criteria
* Subjects with anterior chamber IOLs Prior SLT or stent implantation in study eye Traumatic, uveitic, or neovascular glaucoma Fellow eye BCVA worse than 20/200
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 20% IOP reduction | Month 12 | IOP reduction observed compared to baseline IOP, measured by Goldmann tonometry in mm Hg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IOP less than or equal to 18 mm Hg | Month 12 | IOP compared to baseline IOP, measured by Goldmann tonometry in mm Hg |
Countries
Germany
Outcome results
None listed