Clinical trial NCT01563237: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant
Official title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Lead sponsor: InnFocus Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Eyes With Study Success
timeFrame: Months 6, 9, 12 and 24
Secondary outcomes:
measure: IOP Change From Baseline
timeFrame: At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24
Other outcomes:
Locations:
city: Pessac
country: France
facility: Clinique Mutualiste - Pavillon Ophtalmogique
Study officials:
affiliation: Clinique Mutualiste de Pessac, Pessac, France
name: Isabelle M Riss, MD
role: PRINCIPAL_INVESTIGATOR
References: