The purpose of this research study is to compare the safety and effectiveness of the Aquea Intracanalicular Glaucoma Stent to the Alcon Hydrus Glaucoma Microstent for the reduction of intraocular pressure (IOP) in patients with cataract and primary open angle glaucoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The Zealix stent is a helical shaped stent with variable pitch across the length of the implant specifically designed to keep Schlemm's canal adequately dilated to its natural healthy diameter. The stent has been designed to reduce IOP by restoring the conventional outflow pathway for aqueous humor, specifically Schlemm's canal (SC). Additionally, the Apquea Zealix stent is also designed to provide a by-pass for the aqueous humor fluid to enter Schlemm's canal and flow unobstructed to access the collector channels for drainage.
The Hydrus® Microstent is an FDA approved device. It is a crescent-shaped implantable microstent pre-loaded onto a hand-held delivery system. It is composed of nitinol, a metal alloy of nickel (Ni) and titanium (Ti). The microstent is approximately 8mm in overall length with major and minor axes of 292μm and 185μm, respectively. The length and curvature of the implant are designed to occupy approximately 90° or 3 clock hours of Schlemm's canal. The implant is designed to have adequate structural thickness to support the tissue of the canal while providing maximum open flow areas through the canal, with the proximal portion of the implant exiting the canal through the trabecular meshwork to allow inflow of aqueous humor from the anterior chamber. A further description of the device and delivery system, and a summary of pre-clinical and clinical testing, can be found in Instructions for Use (IFU) provided by the manufacturer with the device
Centro Oftalmologico Robles
Santa Rosa de Copán, Honduras
Primary Effectiveness Endpoint
Proportion of eyes with ≥ 20% decrease in IOP from the hypotensive medication-free baseline examination to the hypotensive medication-free 12-month postoperative examination.
Time frame: 12 Months
Secondary Effectiveness Endpoint
Mean change in IOP between the hypotensive medication-free baseline examination and hypotensive medication-free 12-month postoperative examination.
Time frame: 12 Months
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