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Completed

NCT Number: NCT00772330

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laser Center

Santo Domingo, Dominican Republic

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glaucoma Drainage Device

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

Primary outcomes

  1. 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 outcomes

  1. 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

Other outcomes

  1. Procedure Feasibility

    Time frame: Day 1

    Defined by ease of insertion of the device into the anterior chamber, based on an Investigator evaluation rating (5-point scale, with 1 being difficult and 5 being easy);

  2. Time (in Minutes) Taken for the Procedure

    Time frame: Day 1

    The mean surgical procedure time from the time the incision was made in the conjunctiva to the time peritomy closure

  3. Visual Acuity

    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

    Visual acuity measured at each post-operative visit from baseline.

  4. Visual Field

    Time frame: 60 Months

    Visual field measure at each post op visit. Data not available for summary as per CSR

  5. Incidence of Glaucoma Re-operation

    Time frame: 60 Months

    Cases requiring glaucoma re-operation

  6. Glaucoma Supplemental Medication

    Time frame: Day 1 thru Month 3, Month 6, Month 9, Month 12, Month 24, Month 36, Month 48 and Month 60

    The number of glaucoma supplemental medications required after the MicroShunt procedure.

  7. Implant Migration

    Time frame: 60 Months

    Incidence of implant migration. None reported

  8. Implant Encapsulation

    Time frame: 60 Months

    Incidence of implant encapsulation. None reported

Sponsors and collaborators

Lead sponsor

InnFocus Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2016
Study completion
2017
First posted
Oct 15, 2008
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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