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NCT04014933 | SNCTP000003347

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 19.11.2019), WHO (Imported from 17.11.2019)
Changed: 28.07.2019
Disease category: Augenkrankheiten

Brief description of trial (Source of data: 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 (Source of data: BASEC)

nicht zutreffend

Health conditions (Source of data: WHO)

Open Angle Glaucoma;Normal Tension Glaucoma;Healthy

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Blutfluss der Netzhaut

Interventions (Source of data: WHO)

Diagnostic Test: LASER SPECKLE FLOWGRAPHY

Criteria for participation in trial (Source of data: BASEC)

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

Exclusion criteria (Source of data: BASEC)

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

Inclusion/Exclusion Criteria (Source of data: 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)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04014933

Further information on trial

Date trial registered

03.07.2019

Incorporation of the first participant

01.07.2019

Recruitment status

Recruiting

Academic title (Source of data: 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 (Source of data: WHO)

Observational

Phase (Source of data: WHO)

N/A

Primary end point (Source of data: WHO)

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

Secundary end point (Source of data: WHO)

Cofounder

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Aarau, Zürich

Countries (Source of data: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

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

Contact for general information (Source of data: WHO)

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

Contact for scientific information (Source of data: WHO)

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

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

University of Zurich

Additional sponsors (Source of data : WHO)

Cantonal Hosptial Aarau, Department of Ophthalmology, Aarau, Switzerland

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-00098

Secondary ID (Source of data: WHO)

LSFG Repro