eyeTube in Combination With the eyeWatch Implant

Exclusion Criteria

• •\- Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breast-feeding, inability to understand or give informed consent.
• •Choroidal detachment, choroidal effusion or any active choroidopathy.
• •Diagnosis of acute angle-closure glaucoma or malignant glaucoma.
• •History of glaucoma drainage/valve implant in target quadrant
• •Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathology (e.g. pterygium) in the target quadrant.
• •Use of systemic (oral or intravenous) glaucoma medications
• •History of corneal surgery (including LASIK and PRK), corneal opacities, corneal diseases or any corneal pathology likely to interfere with IOP measurement.
• •Eyes with ocular malformations such as microphthalmia
• •Eyes with concomitant inflammatory/infectious ocular disorders
• •Aphakia
• •Presence of an anterior chamber intraocular lens or implantable contact lens
• •Previous complicated cataract surgery or presence of vitreous in the anterior chamber
• •Cataract surgery performed less than 6 months before the start of the study
• •Presence of intraocular silicone oil
• •Previous diagnosis of chronic uveitis in either eye
• •Active diabetic retinopathy, choroidal neovascularization, secondary retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy or other ophthalmic disease or disorder likely to distort study results.
• •Impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
• •Uncontrolled systemic disease (e.g. diabetes, hypertension)
• •History of dermatological keloid formation
• •Use of ocular or systemic steroids in the last 30 days (chronic continuous use of systemic steroids is permitted) prior to the screening visit, or known response to corticosteroids.
• •Pregnant or breast-feeding women, or women of childbearing age who do not wish to use medically acceptable contraception between the screening visit and the 12-month follow-up visit.
• •Known or suspected allergy or hypersensitivity to any component of the device (e.g. silicone).
• •Current participation or participation within the last 30 days (from the screening visit) in another clinical trial of an investigational drug or interventional device.