Phase
Condition
Open Angle Glaucoma
Glaucoma
Treatment
Minimally Invasive Micro Sclerostomy Device
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, ≥ 40 years to ≤ 85 years old
Inadequately controlled primary open angle glaucoma with screening mean diurnal IOP of ≥ 21 mmHg and ≤ 40 mmHg despite polypharmacy
Primary open angle glaucoma diagnosis based on:
Visual field mean deviation of -3dB or worse and
Glaucomatous optic nerve damage as evidenced by optic disc or retinal nerve fiber layer structural abnormalities documented on slit lamp stereo biomicroscopy or in stereo disc photos
Presence of healthy, free, and mobile conjunctiva in the target quadrant
Prior ab interno conjunctival-sparing glaucoma procedures were conducted more than 6 months prior to enrollment (e.g., iStent, Trabectome, gonioscopy-assisted transluminal trabeculectomy [GATT])
Subject is able and willing to attend all scheduled follow-up exams
Subject understands and signs the informed consent
Study Design
Connect with a study center
Glaucoma Associates of Texas
Dallas, Texas 75231
United StatesActive - Recruiting
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