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

19. oktober 2021 oppdatert av: Allergan

Patient Reported Outcomes for 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.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

28

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Dalhousie University
    • Ontario
      • Kingston, Ontario, Canada, K7K 6Z6
        • Galen Eye Center
      • Mississauga, Ontario, Canada, L5L1W8
        • Prism Eye Institute
      • Toronto, Ontario, Canada, M5G 1Z5
        • Toronto Ophthalmic Research Innovation Centre, Inc
      • Cambridge, Storbritannia, CB2 0QQ
        • Addenbrooke's Hospital
      • Guildford, Storbritannia
        • Royal Surrey County Hospital
      • Southend-on-sea, Storbritannia, SS0 0RY
        • Southend University Hospital
      • Mainz, Tyskland, 55131
        • Universitat Augenklinik
      • Munich, Tyskland, 80336
        • Ludwig-Maximilians-Universität München
      • Tübingen, Tyskland
        • University of Tubingen

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

For this study, approximately 150 eligible patients (75/group) will be enrolled in Canada, the UK, Germany, and Austria.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

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

3 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To evaluate and compare the treatment satisfaction and expectations in patients receiving surgical intervention via XEN and trabeculectomy.
Tidsramme: 3 Months
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.
Tidsramme: 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 Months
To evaluate and compare the visual acuity recovery time in patients receiving surgical intervention via XEN and trabeculectomy.
Tidsramme: 3 Months
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.
Tidsramme: 3 Months
3 Months
To evaluate and compare the IOP (Intraocular Pressure) change from baseline in patients receiving surgical intervention via XEN and trabeculectomy.
Tidsramme: 3 Months
3 Months
To evaluate and compare new onset ocular hypotensive medication use in patients receiving surgical intervention via XEN and trabeculectomy.
Tidsramme: 3 Months
3 Months
To present glaucoma procedure-related adverse events in patients receiving surgical intervention via XEN and trabeculectomy.
Tidsramme: 3 Months
3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by the mean number of physician office visits
Tidsramme: 3 Months
3 Months
To present post-operative medical management in patients receiving surgical intervention via XEN and trabeculectomy.
Tidsramme: 3 Months
3 Months
To evaluate glaucoma related healthcare resource utilization (HRU) by medication use
Tidsramme: 3 Months
3 Months
To present post-operative surgical management in patients receiving surgical intervention via XEN and trabeculectomy
Tidsramme: 3 Months
3 Months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: Joanna Campbell, Ph.D, Allergan

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. februar 2019

Primær fullføring (Faktiske)

9. desember 2020

Studiet fullført (Faktiske)

9. desember 2020

Datoer for studieregistrering

Først innsendt

30. januar 2019

Først innsendt som oppfylte QC-kriteriene

21. februar 2019

Først lagt ut (Faktiske)

25. februar 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. oktober 2021

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P-2016-6380

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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/.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

3
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