two trabecular micro-bypass stents & postoperative travoprost to treat glaucoma subjects on two hypotensive agents

Conditions: Open-angle Glaucoma

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.

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.

Eligibility criteria:
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 exclusion criteria: * aphakic patients or pseudophakic patients with anterior chamber iols (ac-iols) * prior stent implantations (study eye) * traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders * functionally significant visual field loss, including severe nerve fiber bundle defects * prior incisional glaucoma surgery * prior slt within 90 days prior to screening * prior alt * iridectomy or laser iridotomy * ineligibility for ocular hypotensive medication washout period as determined by the investigator. * any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis) * clinically significant corneal dystrophy (e.g., bullous keratopathy, fuch's dystrophy); any guttata * corneal surgery (prior or anticipated) of any type (including lasik, lasek, prk, etc.) that may interfere with iop measurement reliability * corneal opacities that would inhibit visualization of the nasal angle * congenital or traumatic cataract * retinal or optic nerve disorders that are not associated with the existing glaucoma condition * elevated episcleral venous pressure such as associated with: active thyroid orbitopathy; cavernous sinus fistula; sturge-weber syndrome; orbital tumors; orbital congestive disease * clinically significant sequelae from trauma * chronic ocular inflammatory disease or presence of active ocular inflammation baseline exam exclusion criteria: * subject did not complete medication washout * mean iop \ 38 mmhg after anti-glaucoma medication washout * subject does not have a 3mmhg iop increase over screening mean diurnal