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

InnFocus

Status: Completed

Conditions: Glaucoma

Treatments: Device: Glaucoma Drainage Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00772330

INN003

Details and patient eligibility

About

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.

Full 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

Enrollment: 23 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

MIDI Arrow

Experimental group

Description:

Ab externo glaucoma drainage device with no reservoir

Treatment:

Device: Glaucoma Drainage Device