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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01563237
Other study ID # INN004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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