XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
Research type
Research Study
Full title
XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)
IRAS ID
254992
Contact name
Simon Ruben
Contact email
Sponsor organisation
Allergan
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
XEN 45 is a medical device, a gel stent designed to reduce IOP (Intra-ocular pressure) in eyes of individuals with Glaucoma after its insertion in the affected eyes via surgery. Currently, there is no long-term performance and safety data of XEN 45 gel stent surgeries in standard clinical settings. This study will evaluate the long-term performance of the XEN 45 gel stent by measuring the change in IOP and the change in the number of IOP-lowering medication from baseline (i.e., day when decision was made to implant XEN 45 Gel Stent) to 3 and 4 years after XEN 45 Gel Stent implantation. The study population will include patients with one or both eyes with open angle glaucoma that underwent XEN 45 Gel Stent implantation as a standalone procedure or in combination with phacoemulsification (cataract surgery) between 1st January 2014 and 1st October 2015. The study will be conducted at sites where investigators are certified stent surgeons and are known to have implanted stent in the time period being studied. The study period for each eye selected will be from baseline until Last Visit (i.e., date of the last follow-up visit available prior to 1 October 2018 or date on which the patient had a SSI for glaucoma, whichever occurs first). As the study is designed to collect retrospective (historical) data in an anonymized way, informed consent from patients will not be required to collect data from patient’s medical records. Instead, a waiver of consent will be requested from the Ethics Committee. Site staff will assess patient’s medical records and identify patients’ eyes who meet the inclusion/exclusion criteria. After the eyes have been identified, the site staff will analyze the patient’s medical records and extract data to enter into the electronic data capture system.
REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0055
Date of REC Opinion
29 Jan 2019
REC opinion
Favourable Opinion