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

Not Applicable

Completed

Brief Summary: 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: 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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
MIDI Arrow	Glaucoma Drainage Device	Ab externo glaucoma drainage device with no reservoir

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Performance Success	Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60	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).

Secondary Outcome Measures

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