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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
Full 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
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Inclusion criteria
Screening Exam Inclusion Criteria:
Baseline Exam Inclusion Criteria:
Exclusion criteria
Screening Exam Exclusion Criteria:
Baseline Exam Exclusion Criteria:
Primary purpose
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Interventional model
Masking
57 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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