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

Not Applicable

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: MIDI Arrow

• Registration Number: NCT01563237
• Lead Sponsor: InnFocus Inc.

Brief 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.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Results First Submitted: 2021-01-26
• Results First Submitted QC: 2021-05-04
• Results First Posted: 2021-05-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MIDI Arrow	MIDI Arrow	Implantation of MIDI Arrow

Primary Outcome Measures

Name	Time	Method
Number of Eyes With Study Success	Months 6, 9, 12 and 24	The rate of success reflected sustained control of IOP over 24 Months from baseline

Secondary Outcome Measures

Name	Time	Method
IOP Change From Baseline	At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24	Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months.

Trial Locations

Locations (1)

Clinique Mutualiste - Pavillon Ophtalmogique; 🇫🇷 Pessac, France