POST MARKET MULTICENTRIC EVALUATION OF THE AQUESYS XEN IMPLANT
Research type
Research Study
Full title
Post Market Multicentric Evaluation Of The Aquesys Xen Implant In Moderate Primary Open Angle Glaucoma Subjects
IRAS ID
142747
Contact name
Ejaz Ansari
Contact email
Sponsor organisation
Aquesys, Inc.
Clinicaltrials.gov Identifier
Research summary
The goal of this Europe wide study is to collect additional data on the XEN implant, approved for commercial use in Europe, in order to further evaluate the benefits of the glaucoma device in glaucoma suffering patients. The treatment involves the placement of a small implant made of a gelatin-like substance into the eye to drain the excess fluid from the anterior chamber (front part of the eye) into the conjunctival space (behind the front part of the eye). \n\nUp to 200 eyes will be implanted with a XEN Implant in this study. Each patient identified by their physician as potentially suitable will be examined to see if they are eligible to be included in the study. If they are, patients may receive the XEN Implant either in combination with cataract surgery or as a solo implant procedure. The decision as to whether the patient will have cataract surgery at the same time is determined by whether or not the surgeon and patient deem cataract surgery necessary at the time of glaucoma surgery. Each patient will be enrolled in the study for 2 years. \n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/0059
Date of REC Opinion
21 Mar 2014
REC opinion
Further Information Favourable Opinion