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SNCTP000003347 | NCT04014933 | BASEC2019-00098

Reproduzierbarkeit der Messung des Blutflusses in der menschlichen Netzhaut mittels Laser Speckle Flowgraphy System durch das Nidek LSFG-NAVI Gerät.

Data source: BASEC (Imported from 30.04.2024), WHO (Imported from 25.04.2024)
Changed: Dec 23, 2023, 4:22 PM
Disease category: Eye diseases

Brief description of trial (Data source: BASEC)

Wir wollen herausfinden, ob die Messungen mit dem LSFG-Navi Gerät vertrauenswürdig sind und, wie sich der Blutfluss in Glaukom Patienten verändert.

Health conditions investigated(Data source: BASEC)

nicht zutreffend

Health conditions (Data source: WHO)

Open Angle Glaucoma;Normal Tension Glaucoma;Healthy

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Blutfluss der Netzhaut

Interventions (Data source: WHO)

Diagnostic Test: LASER SPECKLE FLOWGRAPHY

Criteria for participation in trial (Data source: BASEC)

Personen mit oder ohne Glaukom
Unterschriebene Einwilligungserklärung
Alter >= 18 Jahre

Exclusion criteria (Data source: BASEC)

Minderjährige Personen
Nicht unterschriebene Einverständniserklärung
Unfähigkeit den Studienablauf zu verstehen, z. B., aufgrund von Sprachschwierigkeiten, psychische Störung, etc.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- signed Patient Informed Consent form

- Be at least 18 years old

- Diagnosis of primary or secondary open-angle glaucoma or normal tension glaucoma or
healthy controls

Exclusion Criteria:

- Age < 18 years

- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant.

- No vulnerable participants will be included in this study.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04014933

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04014933
Further information on trial

Date trial registered

Jul 3, 2019

Incorporation of the first participant

Jul 1, 2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System

Type of trial (Data source: WHO)

Observational

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Coefficients of variation (COV);intraclass correlation coefficients (ICCs)

Secundary end point (Data source: WHO)

Cofounde

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Aarau, Zurich

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

PD Dr. med. Marc Töteberg-Harms
+41 44 255 87 94
marc.toeteberg@usz.ch

Contact for general information (Data source: WHO)

Marc Töteberg-Harms, MD, FEBO
UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland
+41442558794
marc.toeteberg@usz.ch

Contact for scientific information (Data source: WHO)

Marc Töteberg-Harms, MD, FEBO
UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland
+41442558794
marc.toeteberg@usz.ch

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

17.06.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-00098

Secondary ID (Data source: WHO)

LSFG Repro
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