Open Angle Glaucoma
Conditions
Brief summary
This study objective is to evaluate the intraocular pressure (IOP) lowering effect of two trabecular micro-bypass stents (iStent inject) in eyes of subjects with primary open-angle glaucoma on one topical hypotensive medication
Detailed description
The study design is as follows: Prospective Subjects with medicated IOP \> 18 mmHg and ≤ 30 mmHg Subjects on one topical ocular hypotensive medication prior to stent implantation Implantation of two iStent devices (if IOP is \< 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued) IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP Diurnal IOP measurements Follow-up through 60 months postoperative (but could be up to 61 months if subject needs to undergo terminal washout) Descriptive statistics will be tabulated Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion
Interventions
DEVICETwo trabecular micro-bypass stents (iStent inject)
Standalone implantation of two trabecular micro-bypass stents (iStent inject)
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Screening Exam Inclusion Criteria: * Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs). * Primary open-angle glaucoma (including pigmentary or pseudoexfoliative). * Cup-to-disc ratio ≤ 0.9. * Visual field defects, or nerve abnormality characteristic of glaucoma. * One topical hypotensive medication at time of screening exam. * Intraocular pressure (IOP) \> 18 mmHg and ≤ 30 mmHg (medicated) at screening exam. * Study eye BCVA 20/100 or better. * Normal angle anatomy as determined by gonioscopy. * Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent. Baseline Exam Inclusion Criteria: * Subject has completed appropriate medication washout. * Mean IOP \> 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period.
Exclusion criteria
Screening Exam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean intraocular pressure reduction of 20% or more vs baseline | 12 months post-op |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with intraocular pressure less than or equal to 18 mm Hg | 12 months |
Countries
Armenia
Outcome results
None listed