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Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01563237
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
InnFocus Inc.

Study Description
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Brief Summary:
To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Device: MIDI Arrow Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms
Study Start Date : June 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: MIDI Arrow
Implantation of MIDI Arrow
 Device: MIDI Arrow
Implantation of MIDI Arrow
Other Name: Glaucoma drainage device implantation


Outcome Measures
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Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 1 year ]
    Reduction in intraocular pressure relative to the pre-operative value will be assessed with the final measurement of success at twelve months.


Secondary Outcome Measures :
  1. Glaucoma medical therapy [ Time Frame: 1 year ]
    Level of glaucoma supplemental medical therapy with M12 and M24 as endpoint.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient, age 18 to 85 years, inclusive
  2. Patient has primary open angle 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
  3. Patient must have signed and dated the Informed Consent form

Exclusion Criteria:

  1. Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
  2. Pregnant or nursing women.
  3. No light perception.
  4. Active iris neovascularization or active proliferative retinopathy.
  5. Iridocorneal endothelial syndrome.
  6. Epithelial or fibrous downgrowth.
  7. Pseudoexfoliative glaucoma
  8. Aphakia.
  9. Vitreous in anterior chamber for which a vitrectomy is anticipated.
  10. Corneal disease
  11. Acute, chronic or recurrent uveitis.
  12. Severe posterior blepharitis.
  13. Unwilling to discontinue contact lens use after surgery.
  14. Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery.
  15. Prior cataract surgery involving a conjunctival incision
  16. Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period.
  17. Less than 0.1 (20/200) visual acuity in the non-test eye.
  18. Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563237


Locations
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France
Clinique Mutualiste - Pavillon Ophtalmogique
Pessac, France, 33600
Sponsors and Collaborators
InnFocus Inc.
Investigators
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Principal Investigator: Isabelle M Riss, MD Clinique Mutualiste de Pessac, Pessac, France
More Information
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Responsible Party: InnFocus Inc.
ClinicalTrials.gov Identifier: NCT01563237    
Other Study ID Numbers: INN004
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases