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

Primary Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563237
• Other study ID #: INN004
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: January 2017

Study information

• Verified date: June 2021
• Source: InnFocus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

Device:
• MIDI Arrow
Implantation of MIDI Arrow

Locations

Country	Name	City	State
France	Clinique Mutualiste - Pavillon Ophtalmogique	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
InnFocus Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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