NCT01563237

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: InnFocus Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed description

This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.

Conditions

• Primary Open Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	MIDI Arrow	Implantation of MIDI Arrow

Timeline

• Start date: 2011-06-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2012-03-26
• Last updated: 2021-06-24
• Results posted: 2021-05-28

Locations

1 site across 1 country: France