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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2016

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

Interventions

  • Device: Glaucoma Drainage Device
    • 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

Arms, Groups and Cohorts

  • Experimental: MIDI Arrow
    • Ab externo glaucoma drainage device with no reservoir

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Treatment Performance Success
    • Time Frame: 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 Measures

  • Maintenance of Pressure Control
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • InnFocus Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juan F Batlle, MD, Principal Investigator, Laser Center, Santo Domingo, Dominican Republic

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