Two Second-Generation Trabecular Micro-bypass Stents to Treat Glaucoma Subjects on One Hypotensive Medication

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 such as Bjerrum scotoma.
• •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 such as: visual field status would be placed at risk by washout period, or unmedicated IOP after washout period would be expected to exceed upper limit of ≥ 38 mmHg.
• •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 or disorders that would inhibit visualization of the nasal angle.
• •Congenital or traumatic cataract.
• •Retinal or optic nerve disorders, either degenerative or evolutive, 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 (e.g., chemical burns, blunt trauma, etc.).
• •Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis).
• •Pregnant or nursing women.
• •Subject did not complete medication washout.
• •Mean IOP \< 22 mmHg or \> 38 mmHg after anti-glaucoma medication washout.
• •Subject did not have a 3mmHg IOP increase over screening mean diurnal IOP.