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

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

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 Overview

• Status: Completed
• Conditions: Glaucoma

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Dalhousie University
  • Ontario
    • Kingston, Ontario, Canada, K7K 6Z6
      • Galen Eye Center
    • Mississauga, Ontario, Canada, L5L1W8
      • Prism Eye Institute
    • Toronto, Ontario, Canada, M5G 1Z5
      • Toronto Ophthalmic Research Innovation Centre, Inc
• Germany
  • Mainz, Germany, 55131
    • Universitat Augenklinik
  • Munich, Germany, 80336
    • Ludwig-Maximilians-Universität München
  • Tübingen, Germany
    • University of Tubingen
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • Guildford, United Kingdom
    • Royal Surrey County Hospital
  • Southend-on-sea, United Kingdom, SS0 0RY
    • Southend University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For this study, approximately 150 eligible patients (75/group) will be enrolled in Canada, the UK, Germany, and Austria.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Receiving surgical intervention via XEN Gel Stent (XEN); Patient Reported Outcomes (PRO) will be collected before and after this particular procedure
Receiving surgical intervention via trabeculectomy; Patient Reported Outcomes (PRO) will be collected before and after this particular procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits		3 Months
To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.		3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by medication use		3 Months
To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy		3 Months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Joanna Campbell, Ph.D, Allergan

Publications and helpful links

Helpful Links

• To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): December 9, 2020
• Study Completion (Actual): December 9, 2020

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: P-2016-6380

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No