N/A Completed N=69 Treatment

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

Open-angle glaucoma

Source: ClinicalTrials.gov NCT01563237 ↗

Enrolled (actual)

Serious AEs

13.5%

Results posted

May 2021

Primary outcomePrimary: Number of Eyes With Study Success — 50; 52; 50; 51 Implanted eyes

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Eyes With Study Success	50; 52; 50; 51	—
SECONDARY IOP Change From Baseline	26; 9.2; 10.9; 13.2; 13.3; 13.8	—

Eligibility Criteria

Inclusion Criteria

Male or female patient, age 18 to 85 years, inclusive
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
Patient must have signed and dated the Informed Consent form

Exclusion Criteria

Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
Pregnant or nursing women.
No light perception.
Active iris neovascularization or active proliferative retinopathy.
Iridocorneal endothelial syndrome.
Epithelial or fibrous downgrowth.
Pseudoexfoliative glaucoma
Aphakia.
Vitreous in anterior chamber for which a vitrectomy is anticipated.
Corneal disease
Acute, chronic or recurrent uveitis.
Severe posterior blepharitis.
Unwilling to discontinue contact lens use after surgery.
Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery.
Prior cataract surgery involving a conjunctival incision
Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period.
Less than 0.1 (20/200) visual acuity in the non-test eye.
Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01563237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.