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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
InnFocus Inc.
ClinicalTrials.gov Identifier:
NCT01563237
First received: March 21, 2012
Last updated: June 17, 2013
Last verified: March 2012
  Purpose

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 Intervention Phase
Primary Open Angle Glaucoma
Device: MIDI Arrow
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

Resource links provided by NLM:


Further study details as provided by InnFocus Inc.:

Primary Outcome Measures:
  • Intraocular Pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Glaucoma medical therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Level of glaucoma supplemental medical therapy with M12 and M24 as endpoint.


Estimated Enrollment: 55
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIDI Arrow
Implantation of MIDI Arrow
Device: MIDI Arrow
Implantation of MIDI Arrow
Other Name: Glaucoma drainage device implantation

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563237

Locations
France
Clinique Mutualiste - Pavillon Ophtalmogique
Pessac, France, 33600
Sponsors and Collaborators
InnFocus Inc.
Investigators
Principal Investigator: Isabelle M Riss, MD Clinique Mutualiste de Pessac, Pessac, France
  More Information

No publications provided

Responsible Party: InnFocus Inc.
ClinicalTrials.gov Identifier: NCT01563237     History of Changes
Other Study ID Numbers: INN004
Study First Received: March 21, 2012
Last Updated: June 17, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014