Open-angle Glaucoma
Conditions
Brief summary
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
Detailed description
The study design is as follows: * Prospective, single-arm study. * Subjects with open-angle glaucoma and medicated IOP \> 18 mmHg and ≤ 30 mmHg. * Subjects on two topical ocular hypotensive medications (one a prostaglandin). * Implantation of two iStent inject 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. * Follow-up through 60 months postoperative (or 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
PROCEDUREImplantation of two iStent inject micro-bypass stents
\- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
DRUGTopical travoprost
\- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
DEVICETwo iStent inject micro-bypass stents
\- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
DRUGTobramycin
Topical antibiotic (tobramycin): 1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) .
DRUGDexamethasone
Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%): * Week 1: 1 drop four (4) times per day in the study eye * Week 2: 1 drop three (3) times per day in the study eye * Week 3: 1 drop two (2) times per day in the study eye * Week 4: 1 drop one (1) time per day in the study eye
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) * C/D ratio ≤ 0.9 * Visual field defects, or nerve abnormality characteristic of glaucoma * Two topical hypotensive medications at time of screening exam * 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 * A 3mmHg IOP increase over screening mean IOP
Exclusion criteria
Screening Exam
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication | 12 months postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Mean intraocular pressure of 18 mmHg or less versus baseline with reduction of 1 medication | 12 months postoperative |
Countries
Armenia
Outcome results
None listed