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Aquesys XEN Gel Stent Study

Enrollment Status:

Closed to Enrollment

Objective

Open angle glaucoma is the most common type of glaucoma. The XEN Gel Stent has been approved for treating open angle glaucoma in Europe since 2011. Inside the United States, the XEN Gel Stent is an investigational device, which means that it has not been approved by the US Food and Drug Administration (FDA).  The glaucoma specialists at the NYEEIMS has joined Aquesys to evaluate patients with primary open angle glaucoma where previous medical treatments have failed the safety and efficacy of using the XEN Gel Stent as a new way to treat glaucoma.

The XEN Gel Stent is placed in your eye to make a new permanent pathway to reduce the amount of fluid in your eye. This helps preserve your vision by reducing the pressure in your eye to a normal level.

The AqueSys gelatin is well accepted by the human body, and is non-inflammatory. It is a very small tube made of a soft but permanent gelatin material. The implant is 6mm in length and nearly as thin as a strand of human hair. We propose this study will show that the procedure to insert the XEN Gel Stent is more straightforward and less invasive than other similar treatments for glaucoma.

** CLINICAL LANGUAGE

The Xen gel stent is a soft, permanent, non-migrating, subconjunctival implant that shunts fluid from the anterior chamber to the subconjunctival space. It’s a compressible and tissue-conforming hydrophilic implant made of porcine gelatin that’s crosslinked with gluteraldehyde, a material that’s been used for other medical purposes.  The cylindrical, 6mm long implant, comes with three different-size lumens: 45 µm, 63 µm and 140 µm.  Most MIGS devices are designed to enhance normal aqueous outflow through the trabecular meshwork and Schlemm's canal.  This stent is different in that it bypasses the natural drainage pathway and can produce the lower intraocular pressures that we typically only get with trabeculectomy or tube shunt procedures.  There are numerous potential advantages of the Xen gel stent over a trabeculectomy or tube shunt.  It requires only 15-20 minutes to implant, gives you immediate intraocular pressure reduction, and needs relatively little post-operative management. The small luminal diameter of this shunt seems to provide enough resistance to aqueous flow that postoperative hypotony is minimized.  This procedure should be combined with a subconjunctival injection of mitomycin C to enhance long-term intraocular pressure control.  However, like any new procedure, there is a learning curve that must be overcome when these devices are first used.

Enrollment in the Study

Meliza Unson, CRC:                212-979-4672

Katy Tai, CRC:                         212-979-4251, ktai@nyee.edu

Contact Us

Ophthalmology Research AdministrationTel: 646-943-7925

Address310 E. 14th Street
South Building, 5th Floor
New York, NY 10003

Meliza Unson, CRCTel: 212-979-4672

Katy Tai, CRCTel: 212-979-4251

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