Post Market Study of the InnFocus MicroShunt

Study Overview
=================
Brief Summary
-----------------
Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients

Detailed Description
-----------------
The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.

Official Title
-----------------
Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma

Conditions
-----------------
Primary Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: InnFocus MicroShunt implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has mild to moderate primary open glaucoma where the intraocular pressure 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. Primary open angle glaucoma diagnosis based on 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: Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue. 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: 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, pseudo-exfoliative, etc. Chronic ocular inflammatory disease. Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment. 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.). Severe anterior or posterior blepharitis. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment. Prior laser peripheral iridotomy. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA) Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1. Previous cyclodestructive procedure. Use of oral hypotensive glaucoma medications for treatment of the fellow eye. Severe anterior or posterior blepharitis. Unwilling to discontinue contact lens use after surgery. Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment. Presence of an anterior chamber IOL (AC-IOL). Prior laser peripheral iridotomy. Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery during the investigational period. Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA) Known allergy or other contraindication to Mitomycin C (MMC) drug. Angle closure glaucoma or narrow anatomical chamber angle as identified by gonioscopy and classified as Shaffer Grade 0 or 1. 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). 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). Central corneal thickness that is less than 450 microns or greater than 620 microns. Previous cyclodestructive procedure. Prior retinal laser procedure conducted for any purpose other than treatment of retinal tear or hole. Conditions associated with elevated episcleral venous pressure such as 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.) 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), inability to reliably complete visual field testing over the course of the study, uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their participation in the study. Disorders that pose a fall risk, as well as compromise ability to take a visual field exam and take glaucoma medications (e.g., Parkinson's disease), inability to discontinue use of blood thinners within the surgeon's standard preoperative or postoperative instructions. immunodeficiency concerns. known corticosteroid responders whose pressure increases would not allow them to withstand the postop corticosteroid regimen. Intraocular silicone oil. Ocular steroid use in the planned study eye or systemic steroid use anytime within three months of the procedure. (This would not include the use of inhaled or dermatologic steroids.) Chemotherapy within six months of the screening visit. Use of oral hypotensive glaucoma medications for treatment of the fellow eye. A requirement of general anesthesia for the procedure. Bacterial conjunctivitis Bacterial corneal ulcers Endophthalmitis Orbital cellulitis Bacteremia or septicemia Active scleritis Uveitis Severe dry eye syndrome Severe myopia Pseudo-exfoliative glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: InnFocus MicroShunt Surgery<br>InnFocus MicroShunt implantation in the anterior chamber of the eye on patients with primary open angle glaucoma after am antiproliferative treatment of mitomycin C (MMC) | Device: InnFocus MicroShunt implantation<br>* Implantation will include the use of Mitomycin C applied with sponges.<br>* Other names: MIDI Arrow;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Study Success | Rate of success with respect to IOP at Months 6, 9, 12 and 24 on ITT population | Month 6, 9, 12, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP Change | IOP relative to the pre-operative value was assessed at each post-operative visit (Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24). | Day 1, Day 7, Week 4, Month 3, Month 6, Month 9, Month 12, and Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma shunt, glaucoma drainage device