Post market study to evaluate safety and effectiveness of the InnFocus MicroShunt® (MIDI Arrow) in patients with primary open angle glaucoma

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1) Male or female, age 18 to 85 years, inclusive.
2) Subject has mild to moderate primary open glaucoma where the IOP is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or.where glaucoma progression warrants surgery..
3) Primary open angle glaucoma diagnosis based on:
a. 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.
4) Subject willing to comply with study requirements.
5) Subject who has signed an approved informed consent form.

Exclusion Criteria

1) Patient unwilling or unable to give informed consent, or unable to return for scheduled protocol visits through 2 years.
2) Patient < 18 years or >85 years of age.
3) Patient is pregnant or nursing or unable to use appropriate birth control.
4) Vision level of no light perception.
5) Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
6) Iridocorneal endothelial syndrome.
7) Epithelial or fibrous downgrowth.
8) Secondary glaucoma such as post-trauma.
9) Chronic ocular inflammatory disease.
10) Subject already enrolled in this or another study (only one eye can participate in this study) or completed their participation in another study within 30 calendar days of the screening exam.
11) Aphakia.
12) Vitreous in the anterior chamber.
13) Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.).
14) Prior ALT, SLT or MLT within 90 days of enrollment.
15) Severe anterior or posterior blepharitis.
16) Unwilling to discontinue contact lens use after surgery.
17) Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
18) Presence of an anterior chamber IOL (AC-IOL).
19) Prior laser peripheral iridotomy.
20) Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period.
21) Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA)
22) Known allergy or other contraindication to Mitomycin C (MMC) drug.
23) Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1.
24) Any condition that prevents the investigational device implantation or trabeculectomy in the superior region of the study eye (e.g., peripheral anterior synechiae, scleral staphyloma or conjunctival scarring).
25) Diagnosed degenerative visual disorders not associated with existing glaucoma condition (e.g., advanced dry or wet macular degeneration or other retinal disorders, central retinal artery or vein occlusion) or choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or neovascularization).
26) Central corneal thickness that is less than 450 microns or greater than 620 microns.
27) Previous cyclodestructive procedure.
28) Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole.
29) Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease.
30) Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
31) Ocular pathology or medical condition for which, in the investigator's judgment, the following factors would either place the subject at increased risk of complications or contraindicate device implantation or interfere with compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits),
a. inability to reliably complete visual field testing over the course of the study,
b. uncontrolled systemic disease (e.g. diabet