Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

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.

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 < 22 mmHg or > 38 mmHg after anti-glaucoma medication washout
• Subject does not have a 3mmHg IOP increase over screening mean diurnal