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

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

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: MIDI Arrow

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Clinique Mutualiste - Pavillon Ophtalmogique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MIDI Arrow; Implantation of MIDI Arrow	Device: MIDI Arrow; Implantation of MIDI Arrow; Other Names: Glaucoma drainage device implantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: InnFocus Inc.
• Investigators: Principal Investigator: Isabelle M Riss, MD, Clinique Mutualiste de Pessac, Pessac, France

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 23, 2012
• First Posted (ESTIMATE): March 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: INN004