Primary Open Angle Glaucoma Clinical Trial
Official title:
Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms
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 |
Verified date | June 2021 |
Source | InnFocus Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
France | Clinique Mutualiste - Pavillon Ophtalmogique | Pessac |
Lead Sponsor | Collaborator |
---|---|
InnFocus Inc. |
France,
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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