Glaucoma, Glaucoma, Open-Angle
Conditions
Brief summary
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.
Detailed description
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.
Interventions
DEVICEiStent Inject Implantation
Subjects will be implanted with the iStent Injection Micro-Bypass device
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 22 years of age 2. Mild to moderate primary open-angle glaucoma 3. Scheduled to undergo cataract surgery 4. Able and willing to attend scheduled follow-up exams for three years postoperatively 5. Able and willing to provide written informed consent on the IRB approved Informed Consent Form Operative Inclusion Criterion: 6. Successful, uncomplicated cataract surgery
Exclusion criteria
1. Angle closure glaucoma 2. Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle 3. Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| iStent inject placement and stability | 36 Months | The rate of clinically relevant complications associated with iStent inject placement and stability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sight-threatening adverse events | 36 Months | Rate of occurrence of sight-threatening adverse events |
Other
| Measure | Time frame | Description |
|---|---|---|
| Other adverse events | 36 Months | Rate of other adverse events |
Countries
United States
Outcome results
None listed