- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03114059
5 Years Long Term Results After Standalone CyPass-Implantation
Retro- and Prospective Monocentric Study to Evaluate the Safety and Effectiveness of the CyPass Stent 5 Years After Implantation
Studieoversikt
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Mecklenburg/Vorpommern
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Neubrandenburg, Mecklenburg/Vorpommern, Tyskland, 17036
- Dietrich-Bonhoeffer-Klinikum
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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standalone CyPass implantation
patients who have undergone a standalone cypass implantation without cataract surgery more than 3 years ago
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Heidelberg Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological examination
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Patients That Achieve Target Intraocular Pressure Measured in mmHg
Tidsramme: up to 7 years
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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.
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up to 7 years
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Change of Intraocular Pressure in mmHg Preoperatively (at Screening) vs Postoperatively (at Final Examination)
Tidsramme: up to 7 years
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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
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Number of Additional Medication
Tidsramme: up to 7 years
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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
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Number of Participants With Secondary Glaucoma Procedures
Tidsramme: up to 7 years
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To determine the efficacy of CyPass Stent procedure completely the number of secondary glaucoma interventions (surgery/ laser) has to be documented
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up to 7 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants With Stability of Optic Nerve
Tidsramme: up to 7 years
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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
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Number of Participants With Stability of the Retinal Nerve Fiber Layer Thickness
Tidsramme: up to 7 years
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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.
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up to 7 years
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Number of Participants With Stability of Visual Field
Tidsramme: up to 7 years
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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.
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up to 7 years
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Number of Participants With Stability of Stent Position
Tidsramme: up to 7 years
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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
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up to 7 years
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Number of Participants With Stability of Stent Tissue Interaction
Tidsramme: up to 7 years
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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.
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up to 7 years
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Number of Participants With Intra-and Postoperative Complications
Tidsramme: up to 7 years
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The number of intra-and postoperative complications are needed to evaluate the safety of the CyPass-procedure
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up to 7 years
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Number of Participants With Suprachoroidal Bleb
Tidsramme: up to 7 years
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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
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up to 7 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Helmut Hoeh, MD,FEBO, Department of Ophthalmology, Neubrandenburg, Germany
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Garcia-Feijoo J, Rau M, Grisanti S, Grisanti S, Hoh H, Erb C, Guguchkova P, Ahmed I, Grabner G, Reitsamer H, Shaarawy T, Ianchulev T. Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study. Am J Ophthalmol. 2015 Jun;159(6):1075-1081.e1. doi: 10.1016/j.ajo.2015.02.018. Epub 2015 Mar 3.
- Hoeh H, Vold SD, Ahmed IK, Anton A, Rau M, Singh K, Chang DF, Shingleton BJ, Ianchulev T. Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent. J Glaucoma. 2016 Jan;25(1):106-12. doi: 10.1097/IJG.0000000000000134.
- Grisanti S, Margolina E, Hoeh H, Rau M, Erb C, Kersten-Gomez I, Dick HB, Grisanti S. [Supraciliary microstent for open-angle glaucoma: clinical results of a prospective multicenter study]. Ophthalmologe. 2014 Jun;111(6):548-52. doi: 10.1007/s00347-013-2927-6. German.
- Hoh H, Grisanti S, Grisanti S, Rau M, Ianchulev S. Two-year clinical experience with the CyPass micro-stent: safety and surgical outcomes of a novel supraciliary micro-stent. Klin Monbl Augenheilkd. 2014 Apr;231(4):377-81. doi: 10.1055/s-0034-1368214. Epub 2014 Apr 25.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STI 06/16
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IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
Legemiddel- og utstyrsinformasjon, studiedokumenter
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