Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

Study Overview
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Brief Summary
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To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg

Detailed Description
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This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.

Official Title
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Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

Conditions
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Primary Open Angle Glaucoma

Intervention / Treatment
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* Device: MIDI Arrow


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient, age 18 to 85 years, inclusive Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg Patient must have signed and dated the Informed Consent form Exclusion Criteria: Unwilling or unable to give informed consent or unable to return for scheduled protocol visits. Pregnant or nursing women. No light perception. Active iris neovascularization or active proliferative retinopathy. Iridocorneal endothelial syndrome. Epithelial or fibrous downgrowth. Pseudoexfoliative glaucoma Aphakia. Vitreous in anterior chamber for which a vitrectomy is anticipated. Corneal disease Acute, chronic or recurrent uveitis. Severe posterior blepharitis. Unwilling to discontinue contact lens use after surgery. Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery. Prior cataract surgery involving a conjunctival incision Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period. Less than 0.1 (20/200) visual acuity in the non-test eye. Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIDI Arrow<br>Implantation of MIDI Arrow | Device: MIDI Arrow<br>* Implantation of MIDI Arrow<br>* Other names: Glaucoma drainage device implantation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eyes With Study Success | The rate of success reflected sustained control of IOP over 24 Months from baseline | Months 6, 9, 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP Change From Baseline | Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months. | At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24 |