PROs for XEN Gel Stent versus Trabeculectomy Treatment of Glaucoma
Research type
Research Study
Full title
Patient Reported Outcomes for XEN Gel Stent versus Trabeculectomy for the Treatment of Glaucoma
IRAS ID
256613
Contact name
Maria Teresa Abunto
Contact email
Sponsor organisation
Allergan
Clinicaltrials.gov Identifier
256613, IRAS Project ID
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Glaucoma is a medical condition where the fluid in the eye is unable to drain properly causing an increase in pressure in the eye. When the pressure in the eye gets too high, parts of the eye can become damaged, and if left untreated can result in vision loss and blindness. Surgical procedures to treat glaucoma aim to help the fluid flow out of the eye resulting in lower eye pressure, and minimizing the risk of further vision loss.
XENPRO is a research study for glaucoma patients already scheduled to receive surgery for glaucoma with either XEN Gel Stent or trabeculectomy surgical procedures.
The purpose of this study is to assess how well XEN Gel Stent and trabeculectomy work to treat glaucoma and to gain the patient’s point of view on treatment satisfaction, vision-related problems, and work productivity after either of these two procedures. For this study, data on each study participant’s treatment will be collected along with information on how well the surgical procedure worked to treat their glaucoma as well as their satisfaction with the outcome of either the XEN Gel Stent or trabeculectomy procedure.
XENPRO, is a type of research study referred to as observational. All procedures and medications study participants will receive are considered standard of care for patients with glaucoma receiving either XEN Gel Stent or trabeculectomy surgery. Patients will not receive any medication, treatment or undergo any additional procedures as a part of this study. During this observational study, information will be collected from the patient’s via surveys at select time points. Glaucoma treatment will be managed by the participant’s regular doctor and health care provider(s). Participation in this study will not influence the medical care each study participant will receive or the treatment prescribed.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0060
Date of REC Opinion
15 Feb 2019
REC opinion
Further Information Favourable Opinion