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

Sponsor

Allergan (Industry)

Overall Status

Completed

CT.gov ID

NCT03852810

Collaborator

(none)

Enrollment

Locations

21.5

Actual Duration (Months)

2.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Glaucoma

Study Design

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 :

Feb 25, 2019

Actual Primary Completion Date :

Dec 9, 2020

Actual Study Completion Date :

Dec 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy. [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

To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy. [3 Months]
Patients treatment satisfaction and expectations will be measured using a study specific Glaucoma Surgery Satisfaction Survey.
To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy. [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
To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy. [3 Months]
Visual acuity will be recorded from the patient chart and converted from the site-specific metric to EDTRS letter equivalents
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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

Sponsors and Collaborators

Allergan

Investigators

Study Director: Joanna Campbell, Ph.D, Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Allergan

ClinicalTrials.gov Identifier:

NCT03852810

Other Study ID Numbers:

P-2016-6380

First Posted:

Feb 25, 2019

Last Update Posted:

Oct 20, 2021

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Oct 20, 2021