The study objective is to assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications. The goal is to provide a safe, effective, intuitively performed alternative for the surgical treatment of glaucoma.
About InnFocus MicroShunt Device
The lumen of the device is approximately 70 microns in diameter with an outer diameter of 350 microns and a length of approximately 8.5mm. It is designed to allow aqueous flow from the anterior chamber to a bleb (blister-like formation below the conjunctiva/Tenons).
- Male or female patient, age 40 to 85 years, inclusive
- Patient has early to severe primary open angle glaucoma where the mean diurnal intraocular pressure is not controlled on maximum tolerated medical therapy with intraocular pressure ≥ 15 mm Hg and ≤ 40 mm Hg while on glaucoma medications. [Maximum tolerated medical therapy is defined as three or more classes of topical glaucoma medications (prostaglandin analog, beta–adrenergic antagonist, carbonic anhydrase inhibitor, alpha-adrenergic agonist, parasympathomimetic). If a subject is intolerant to specific glaucoma medications or the medications are ineffective, “maximum tolerated glaucoma medications” may be fewer than three classes presently in use. Combination glaucoma medications that consist of two or more glaucoma drugs will have each glaucoma drug component counted as a separate drug.]
- Primary open angle glaucoma diagnosis based on:
a. visual field mean deviation of -3dB or worse and
b. glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos: 1) Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles; 2) Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; 3) Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue; 4) Disc rim or peripapillary retinal nerve fiber layer hemorrhages
- Patient is willing to attend follow-up visits for two years postoperatively.
All criteria apply to the study eye unless otherwise noted:
- Patient unwilling or unable to give informed consent, unwilling to accept randomization, or unable to return for scheduled protocol visits through 2 years.
- Patient < 40 years or >85 years of age.
- Patient is pregnant or nursing or unable to use appropriate birth control.
- Vision level of no light perception.
- Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results
- Iridocorneal endothelial syndrome.
- Epithelial or fibrous downgrowth.
- Secondary glaucoma such as post-trauma, pseudoexfoliation or pigment dispersion
- Chronic ocular inflammatory disease.
Enrollment in the Study
Meliza Unson, CRC: 212-979-4672
Katy Tai, CRC: 212-979-4251, email@example.com