This is a prospective, observational, non-interventional study of patients scheduled to receive surgical intervention either via XEN or trabeculectomy for open-angle glaucoma. The decision to treat patients with a particular surgical procedure will not be influenced by the study as the treatment decision will continue to be made by the patient and the clinician. There will be no study mandated visits or treatments.
Study Type
OBSERVATIONAL
Enrollment
28
Dalhousie University
Halifax, Nova Scotia, Canada
Galen Eye Center
Kingston, Ontario, Canada
Prism Eye Institute
Mississauga, Ontario, Canada
Toronto Ophthalmic Research Innovation Centre, Inc
To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy.
Visual function and local eye symptoms using the Glaucoma Symptom and Health Problem Chart (SHPC-18) SHPC-18 is an eighteen question survey to assess local eye and visual function symptoms caused by glaucoma or its treatments. The tool is comprised of 7 questions related to local eye symptoms, and 11 related to visual function problems. The 2-domain tool is a psychometrically validated measure of patient-reported, glaucoma-related symptoms that is responsive to treatment and discriminates the severity of glaucoma to better understand the influence of glaucoma symptoms on patients' daily life.
Time frame: 3 Months
To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy.
Patients treatment satisfaction and expectations will be measured using a study specific Glaucoma Surgery Satisfaction Survey.
Time frame: 3 Months
To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy.
Work productivity using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem v2.0 (WPAI:SHP) The WPAI is a six question survey to quantitatively assess the amount of absenteeism, presenteeism, and daily activity impairment attributable to specific health problems. Participants will be asked about their employment status, the amount of hours they have missed due to their health problems, the amount of hours they have missed due to non-health problems, how many hours they worked, how much their health problems affected work productivity, and how much their health problems affected their regular daily activities for the recall period of one week
Time frame: 3 Months
To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.
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Toronto, Ontario, Canada
Universitat Augenklinik
Mainz, Germany
Ludwig-Maximilians-Universität München
Munich, Germany
University of Tübingen
Tübingen, Germany
Addenbrooke's Hospital
Cambridge, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
Southend University Hospital
Southend-on-Sea, United Kingdom
Visual acuity will be recorded from the patient chart and converted from the site-specific metric to EDTRS letter equivalents
Time frame: 3 Months
To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits
Time frame: 3 Months
To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.
Time frame: 3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by medication use
Time frame: 3 Months
To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy
Time frame: 3 Months