Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Study Overview
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Brief Summary
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Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from 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.

Detailed Description
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Unicentric, non-randomized, single arm safety and performance study which will be conducted in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I & II: 2003 on clinical investigations with medical devices on human subjects and recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions

Official Title
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Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Glaucoma Drainage Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18 to 85 years, inclusive 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 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 Aphakia (without pseudophakia) Vitreous in anterior chamber for which a vitrectomy is anticipated Chronic or recurrent uveitis Severe posterior blepharitis Unwilling to discontinue contact lens use after surgery Previous ophthalmic surgery, excluding uncomplicated phacoemulsification (cataract) surgery or corneal refractive surgery Need for glaucoma surgery combined with other ocular procedures other than cataract surgery (i.e., penetrating keratoplasty or retinal surgery) or anticipated need for additional ocular surgery Known allergy to Mitomycin C (MMC) drug.

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>Ab externo glaucoma drainage device with no reservoir | Device: Glaucoma Drainage Device<br>* Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment Performance Success | Success: IOP < 15 mmHg or IOP reduced from baseline (pre-operative level) by ≥ 20% (without glaucoma reoperation, such as a trabeculectomy to improve aqueous drainage or implantation of another drainage implant). | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of Pressure Control | Maintenance of pressure control throughout the follow-up period, as measured by IOP at each post-operative visit | Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIDI Arrow, Glaucoma Drainage Device, GDD, InnFocus, Glaucoma treatment