Satisfaction With XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma

Glaucoma Clinical Trial

— XENPRO  

Official title:

Patient Reported Outcomes for XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852810
• Other study ID #: P-2016-6380
• Status: Completed
• Start date: February 25, 2019
• Est. completion date: December 9, 2020

Study information

• Verified date: February 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with OAG (Open Angle Glaucoma) and using at least 2 topical IOP-lowering medication classes in the study eye

• Scheduled to receive surgical treatment with either XEN (Xen gel stent) or trabeculectomy in the study eye

• Access to an electronic device with internet capabilities and an email address for completion of PROs (Patient Reported Outcomes)

• Be willing and able to complete PROs (Patient Reported Outcomes) at the specified time points

• Able to provide voluntary, informed consent to participate in this study

Exclusion Criteria:

• Diagnosed with angle closure glaucoma in the study eye

• Presence of a secondary glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma

• Presence of neovascular, uveitic, or angle recession glaucoma or any glaucoma associate with vascular disorders

• Prior incisional glaucoma surgery, canal-based surgery, suprachoroidal space-based surgery (trabeculectomy, viscocanalostomy, canaloplasty, shunts of any type, collagen implants, etc.) or a cilio-ablative procedure

• Clinically significant inflammation or infection in the study eye within 30 days prior to the baseline visit (e.g. blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)

• History of corneal surgery, corneal opacities, or corneal disease

• Prior intraocular surgery in either eye = 3 months prior to study enrollment with the exception of uncomplicated cataract surgery in either eye = 1 month prior to study enrollment

• Anticipated ocular surgery in either eye within 6 months of baseline

• Concomitant cataract surgery scheduled at the time of glaucoma procedure

The study eye is defined as the eye receiving surgical intervention with either XEN or trabeculectomy.

Patients who have received prior laser trabeculoplasty will be permitted to participate if all other inclusion/exclusion criteria are met.

Related Conditions & MeSH terms

• Glaucoma

Locations

Country	Name	City	State
Canada	Dalhousie University	Halifax	Nova Scotia
Canada	Galen Eye Center	Kingston	Ontario
Canada	Prism Eye Institute	Mississauga	Ontario
Canada	Toronto Ophthalmic Research Innovation Centre, Inc	Toronto	Ontario
Germany	Universitat Augenklinik	Mainz
Germany	Ludwig-Maximilians-Universität München	Munich
Germany	University of Tübingen	Tübingen
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Southend University Hospital	Southend-on-sea

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Canada,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 Months
Secondary	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.	3 Months
Secondary	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	3 Months
Secondary	To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.	Visual acuity will be recorded from the patient chart and converted from the site-specific metric to EDTRS letter equivalents	3 Months
Secondary	To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
Secondary	To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
Secondary	To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
Secondary	To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
Secondary	To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits		3 Months
Secondary	To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
Secondary	To evaluate glaucoma related healthcare resource utilization (HRU) by medication use		3 Months
Secondary	To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy		3 Months

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance
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