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5 Years Long Term Results After Standalone CyPass-Implantation

17. marts 2022 opdateret af: Dietrich-Bonhoeffer-Klinikum

Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation

This study evaluates the results of all clinically relevant findings of glaucoma diagnostics 5 Years after stent-implantation concerning the safety and effectiveness of the cypass stent procedure. The comparison of Preoperative and long term postoperative results is the aim of this study to evaluate this young procedure of Glaucoma surgery

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a post market study without interventions.The participants have been treated with CyPass-Stent implantation between 3 and 7 years ago to control the intraocular pressure . They will be invited for only one follow up visit to determine the present glaucoma status again, to determine the long term safety and effectiveness of the cypass stent procedure and to see whether addition therapy or surgical intervention is necessary.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

230

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Mecklenburg/Vorpommern
      • Neubrandenburg, Mecklenburg/Vorpommern, Tyskland, 17036
        • Dietrich-Bonhoeffer-Klinikum

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

130 Patient with at least one treated eye

Beskrivelse

Inclusion Criteria:

  • patients who have undergone a standalone cypass implantation at least 3 years ago
  • signed inform consent

Exclusion Criteria:

  • Patients with too much travel distance between study center and home
  • Patients who cannot visit the studycenter due to health problems

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
standalone CyPass implantation
patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
Diagnostisk test: Glaucoma diagnostics
Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
Tidsramme: up to 7 years
The Measurement of the intraocular Pressure is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative target pressure of 15 mmHg, 18 mmHg or 21 mmHg (depends on Glaucoma Status) has to be achieved.
up to 7 years
Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
Tidsramme: up to 7 years

The Measurement of the intraocular Pressure change is a criterion for the Efficacy of CyPass Stent Procedure (success rate). The postoperative pressure after 5 to 7 years has to be compared with the preoperative intraocular pressure (in mmHg)

The change was calculated only from two time points. (value at the final examination time point minus the value at the preoperative time point
up to 7 years
Number of Additional Medication
Tidsramme: up to 7 years

The number of additional Glaucoma medication is another criterion to determine the Efficacy of CyPass Stent Procedure (success rate). Up to 4 different active substance can be used to reduce the pressure. The more substances the patient uses postoperatively the lower is the success after implantation of the CyPass-Stent.

The postoperative number of medications after 5 years has to be compared with the preoperative number
up to 7 years
Number of Participants With Secondary Glaucoma Procedures
Tidsramme: up to 7 years
To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented
up to 7 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Stability of Optic Nerve
Tidsramme: up to 7 years

The Measurement of the optic nerve (HRT) in comparison to the baseline is needed to evaluate the glaucoma damage and to determine the Longterm success rate and the safety of the CyPass- Stent-Procedure.

With papillary tomography you can see the changes in the optic nerve head concerning the permanent failures of retinal vessels , measure them very precisely and compare them with the previous findings.
up to 7 years
Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness
Tidsramme: up to 7 years
The comparison of the preoperative and postoperative Status of the Retinal Nerve Fiber Layer Thickness and retinal fundus thickness is another criterion to determine the absolute and relative success.
up to 7 years
Number of Participants With Stability of Visual Field
Tidsramme: up to 7 years
The parameter of the Visual Field (Mean Deviation) will be measured to evaluate the Safety of the CyPass-Procedure. The visual Field shows the progression of glaucoma defects concerning failures in different parts for example in the center or in the periphery of the visual field.
up to 7 years
Number of Participants With Stability of Stent Position
Tidsramme: up to 7 years
Determination of Stent Position in the angle will be performed to exclude moving of the Stent. The stent could change it's position forward into the anterior chamber or backwards in the suprachorioidal space
up to 7 years
Number of Participants With Stability of Stent Tissue Interaction
Tidsramme: up to 7 years
Determination of iris tissue reaction to the stent will be performed. We document slight reaction without involving the opening, iris reaction with involving the opening and complete closure by tissue. The iris Tissue could overgrow the opening of the stent and therfore the function of the stent is disturbed or even failed.
up to 7 years
Number of Participants With Intra-and Postoperative Complications
Tidsramme: up to 7 years
The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure
up to 7 years
Number of Participants With Suprachoroidal Bleb
Tidsramme: up to 7 years
The Determination of the suprachoroidal bleb is needed to evaluate the function of the stent and the efficacy of the procedure. The bigger the bleb, the lower the pressure and the better the efficacy of the stent
up to 7 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dietrich-Bonhoeffer-Klinikum

Efterforskere

  • Ledende efterforsker: Helmut Hoeh, MD,FEBO, Department of Ophthalmology, Neubrandenburg, Germany

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2017

Primær færdiggørelse (Faktiske)

28. februar 2018

Studieafslutning (Faktiske)

1. april 2020

Datoer for studieregistrering

Først indsendt

4. april 2017

Først indsendt, der opfyldte QC-kriterier

10. april 2017

Først opslået (Faktiske)

14. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. marts 2022

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STI 06/16

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

results will be published in ophthalmological journals

IPD-delingstidsramme

results are planned to published in December 2020

IPD-delingsadgangskriterier

Publication in ophthalmological journals provided and checked by Ahmed Medra

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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