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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:
Information provided by (Responsible Party):
InnFocus Inc.
ClinicalTrials.gov Identifier:
NCT00772330
First received: October 13, 2008
Last updated: April 3, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention Phase
Glaucoma Device: Glaucoma Drainage Device Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Resource links provided by NLM:


Further study details as provided by InnFocus Inc.:

Primary Outcome Measures:
  • Reduction in intraocular pressure relative to the pre-operative value [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 23
Study Start Date: October 2007
Study Completion Date: January 2017
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIDI Arrow
Ab externo glaucoma drainage device with no reservoir
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

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772330

Locations
Dominican Republic
Laser Center
Santo Domingo, Dominican Republic
Sponsors and Collaborators
InnFocus Inc.
Investigators
Principal Investigator: Juan F Batlle, MD Laser Center, Santo Domingo, Dominican Republic
  More Information

Responsible Party: InnFocus Inc.
ClinicalTrials.gov Identifier: NCT00772330     History of Changes
Other Study ID Numbers: INN003
Study First Received: October 13, 2008
Last Updated: April 3, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by InnFocus Inc.:
MIDI Arrow
Glaucoma Drainage Device
GDD
InnFocus
Glaucoma treatment

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on June 23, 2017