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

19 oktober 2021 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

28

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / 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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Studierektor: Joanna Campbell, Ph.D, Allergan

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 februari 2019

Primärt slutförande (Faktisk)

9 december 2020

Avslutad studie (Faktisk)

9 december 2020

Studieregistreringsdatum

Först inskickad

30 januari 2019

Först inskickad som uppfyllde QC-kriterierna

21 februari 2019

Första postat (Faktisk)

25 februari 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

20 oktober 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 oktober 2021

Senast verifierad

1 februari 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • P-2016-6380

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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/.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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