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Completed

NCT Number: NCT03852810

Satisfaction With 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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalhousie University, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Acronym: XENPRO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 25, 2019
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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