Clinical trial NCT03852810: Satisfaction With XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
Official title: Patient Reported Outcomes for XEN Gel Stent Versus Trabeculectomy for the Treatment of Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: To evaluate and compare the visual function and local eye symptoms in patients receiving surgical intervention via XEN (Xen gel stent) or trabeculectomy.
timeFrame: 3 Months
Secondary outcomes:
measure: To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate and compare work productivity in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate and compare the refractive change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits
timeFrame: 3 Months
measure: To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.
timeFrame: 3 Months
measure: To evaluate glaucoma related healthcare resource utilization (HRU) by medication use
timeFrame: 3 Months
measure: To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy
timeFrame: 3 Months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University
state: Nova Scotia
city: Kingston
country: Canada
facility: Galen Eye Center
state: Ontario
city: Mississauga
country: Canada
facility: Prism Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: Toronto Ophthalmic Research Innovation Centre, Inc
state: Ontario
city: Mainz
country: Germany
facility: Universitat Augenklinik
city: Munich
country: Germany
facility: Ludwig-Maximilians-Universität München
city: Tübingen
country: Germany
facility: University of Tübingen
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital
city: Southend-on-sea
country: United Kingdom
facility: Southend University Hospital
Study officials:
affiliation: Allergan
name: Joanna Campbell, Ph.D
role: STUDY_DIRECTOR
References: