Clinical Study Evaluating the Safety and Performance of the MIST Device for Intraocular Pressure Reduction in Patients With Primary Open-Angle Glaucoma

Exclusion Criteria

• •Prior glaucoma filtering surgery (trabeculectomy, shunt or valve) in the treatment quadrant
• •Angle-closure, neovascular, uveitic, or traumatic glaucoma.
• •Eyes with conjunctival scarring, prior conjunctival surgery or other pathologies in the treatment quadrant
• •Eyes with scleral thinning, staphyloma, or structural abnormalities in the treatment quadrant
• •Uncontrolled IOP \> 35 mmHg at screening.
• •Active ocular infection or inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis).
• •Active or recent (within 6 months) iris neovascularization in the treatment quadrant
• •Impaired episcleral venous drainage
• •Anterior chamber intraocular lens
• •Patients with uncontrolled bleeding disorders or those receiving anticoagulation therapy without appropriate perioperative management
• •Advanced glaucomatous optic neuropathy.
• •Fuchs endothelial dystrophy with clinical signs of endothelial decompensation.
• •Central corneal thickness (CCT) \> 600 μm.
• •Pathological myopia.
• •Patients unable to comply with postoperative follow-up or treatment instructions
• •Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception as outlined below are excluded:
• •* Hormonal methods and the intrauterine device (IUD) must be in use at least 30 days prior to first study drug administration
• •* Barrier methods must be in use at least 14 days prior to study drug administration
• •* Your male partner vasectomy must be completed 3 months prior to first study drug administration or a sperm count of 0 should be confirmed.