Clinical trial NCT04014933: Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
Official title: Prospective, Non-randomised, Non-controlled Study of Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Normal Tension Glaucoma
Healthy
Keywords: glaucoma
retinal blood flow
ocular perfusion pressure
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 groups as described above will be recruted from the outpatient department of the Ophthalmology Department at the UniversityHospital Zurich, Zurich, Switzerland and the Ophthalmology Department at the Cantonal Hospital Aarau, Aarau, Switzerland

Brief summary: In addition to intraocular pressure blood perfusion pressure in the optic nerve is an important factor determing the cause of glaucoma. Increasing evidence suggests that in glaucoma patients retinal blood may be decreased.

Detailed description: According to the World Health Organization (WHO) glaucoma is the second leading cause of blindness. Glaucoma is a global problem, which is becoming even more important as the human life expectancy increases. Although the causes of glaucoma are uncertain, mainly intraocular pression (IOP), genetics, and ocular blood perfusion pressure in the optic nerve determine the cause of the disease. Increasing evidence suggests that in glaucoma patients retinal blood flow is decreased leading to progression and to damage of the optic nerve.

In order to measure the peripapillary blood flow a variety of devices using different techniques of flowmetry have been developed. In this study, the reproducibility of the retinal flowmetry measured with the LSFG-NAVI device from Nidek will be investigated. A high reproducibility is crucial for the clinical value of any measuring device.

Eligibility criteria: 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.

Primary outcomes:
measure: Coefficients of variation (COV)
timeFrame: 1 month
measure: intraclass correlation coefficients (ICCs)
timeFrame: 1 month
Secondary outcomes:
measure: Cofounder
timeFrame: 1 month
measure: Cofounder
timeFrame: 1 month
measure: Cofounder
timeFrame: 1 month
measure: Cofounder
timeFrame: 1 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Ophthalmology
state: ZH
Study officials:
affiliation: UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland
name: Marc Töteberg-Harms, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References: