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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00772330
First Posted: October 15, 2008
Last Update Posted: April 4, 2017
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.
Information provided by (Responsible Party):
InnFocus Inc.
October 13, 2008
October 15, 2008
April 4, 2017
October 2007
November 2016   (Final data collection date for primary outcome measure)
Reduction in intraocular pressure relative to the pre-operative value [ Time Frame: 12 months ]
Not Provided
Complete list of historical versions of study NCT00772330 on ClinicalTrials.gov Archive Site
  • Visual acuity [ Time Frame: 12 months ]
  • Ease of device insertion [ Time Frame: Day 0 ]
  • Time taken for procedure [ Time Frame: Day 0 ]
  • Incidence of glaucoma re-operation [ Time Frame: 12 months ]
  • Visual field [ Time Frame: 12 months ]
  • Incidence of eye-related supplemental medical therapy [ Time Frame: 12 months ]
  • Incidence of implant migration [ Time Frame: 12 months ]
  • Incidence of implant encapsulation [ Time Frame: 12 months ]
Not Provided
Not Provided
Not Provided
 
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Glaucoma
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
Experimental: MIDI Arrow
Ab externo glaucoma drainage device with no reservoir
Intervention: Device: Glaucoma Drainage Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
January 2017
November 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Dominican Republic
 
 
NCT00772330
INN003
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
InnFocus Inc.
InnFocus Inc.
Not Provided
Principal Investigator: Juan F Batlle, MD Laser Center, Santo Domingo, Dominican Republic
InnFocus Inc.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP