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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852810
Recruitment Status : Completed
First Posted : February 25, 2019
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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Brief 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.

Condition or disease
Glaucoma

Study Design
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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Patient Reported Outcomes for XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
Actual Study Start Date : February 25, 2019
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : December 9, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy. [ Time Frame: 3 Months ]

    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.



Secondary Outcome Measures :
  1. To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
    Patients treatment satisfaction and expectations will be measured using a study specific Glaucoma Surgery Satisfaction Survey.

  2. To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]

    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. To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
    Visual acuity will be recorded from the patient chart and converted from the site-specific metric to EDTRS letter equivalents

  4. To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
  5. To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
  6. To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
  7. To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
  8. To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits [ Time Frame: 3 Months ]
  9. To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy. [ Time Frame: 3 Months ]
  10. To evaluate glaucoma related healthcare resource utilization (HRU) by medication use [ Time Frame: 3 Months ]
  11. To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy [ Time Frame: 3 Months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852810


Locations
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Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Galen Eye Center
Kingston, Ontario, Canada, K7K 6Z6
Prism Eye Institute
Mississauga, Ontario, Canada, L5L1W8
Toronto Ophthalmic Research Innovation Centre, Inc
Toronto, Ontario, Canada, M5G 1Z5
Germany
Universitat Augenklinik
Mainz, Germany, 55131
Ludwig-Maximilians-Universität München
Munich, Germany, 80336
University of Tübingen
Tübingen, Germany
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
Royal Surrey County Hospital
Guildford, United Kingdom
Southend University Hospital
Southend-on-sea, United Kingdom, SS0 0RY
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joanna Campbell, Ph.D Allergan
More Information
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Additional Information:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03852810    
Other Study ID Numbers: P-2016-6380
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases