Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma

InnFocus Inc.6 sites in 4 countries107 target enrollmentApril 4, 2014

ConditionsPrimary Open Angle Glaucoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Primary Open Angle Glaucoma
Sponsor: InnFocus Inc.
Enrollment: 107
Locations: 6
Primary Endpoint: Number of Participants With Study Success
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, multicentric, single arm post market study to gather safety and effectiveness data on the CE Marked InnFocus MicroShunt (MIDI Arrow) device in primary open angle glaucoma patients

Detailed Description

The purpose of this study is to collect additional safety and effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma who are inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg and/or where glaucoma progression warrants surgery.

Registry

clinicaltrials.gov

Start Date

April 4, 2014

End Date

November 27, 2017

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

InnFocus Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has mild to moderate primary open glaucoma where the intraocular pressure is not adequately controlled on maximum tolerated medical therapy and has intraocular pressure greater than or equal to 18mmHg and less than or equal to 35mmHg while on glaucoma medications and/or where glaucoma progression warrants surgery.
•Primary open angle glaucoma diagnosis based on glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos:
•Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles.
•Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles.
•Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.
•Disc rim or peripapillary retinal nerve fiber layer hemorrhages.
•Subject willing to comply with study requirements. 5) Subject who has signed an approved informed consent form

Exclusion Criteria

•Active iris neovascularization, active proliferative retinopathy or other ophthalmic disease that could confound study results.
•Iridocorneal endothelial syndrome.
•Epithelial or fibrous downgrowth.
•Secondary glaucoma such as post-trauma, pseudo-exfoliative, etc.
•Chronic ocular inflammatory disease.
•Prior argon laser, selective laser, or micropulse trabeculoplasty within 90 days of enrollment.
•Inability to obtain accurate IOP measurement throughout the study. For example: a history of corneal surgery, corneal opacities or disease/pathology (Active corneal infection or Fuchs dystrophy are examples.).
•Severe anterior or posterior blepharitis.
•Previous incisional ophthalmic surgery, excluding uncomplicated clear corneal phacoemulsification (cataract) surgery at least 6 months prior to enrollment.
•Prior laser peripheral iridotomy.