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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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For this study, approximately 150 eligible patients (75/group) will be enrolled in Canada, the UK, Germany, and Austria.
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| Name | Affiliation | Role |
|---|---|---|
| Joanna Campbell, Ph.D | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalhousie University | Halifax | Nova Scotia | B3H 2Y9 | Canada | ||
| Galen Eye Center |
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| Label | URL |
|---|---|
| To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link. | View source |
| 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 | View source |
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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/.
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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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 |
| Kingston |
| Ontario |
| K7K 6Z6 |
| Canada |
| Prism Eye Institute | Mississauga | Ontario | L5L1W8 | Canada |
| Toronto Ophthalmic Research Innovation Centre, Inc | Toronto | Ontario | M5G 1Z5 | Canada |
| Universitat Augenklinik | Mainz | 55131 | Germany |
| Ludwig-Maximilians-Universität München | Munich | 80336 | Germany |
| University of Tübingen | Tübingen | Germany |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Royal Surrey County Hospital | Guildford | United Kingdom |
| Southend University Hospital | Southend-on-Sea | SS0 0RY | United Kingdom |