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Reproducibility of Blood Flowmetry in Human Retina Using the Nidek Laser Speckle Flowgraphy LSFG-NAVI System

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04014933
Acronym
LSFG Repro
Enrollment
44
Registered
2019-07-10
Start date
2019-07-01
Completion date
2021-12-31
Last updated
2023-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Normal Tension Glaucoma, Open Angle Glaucoma

Keywords

glaucoma, retinal blood flow, ocular perfusion pressure

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.

Interventions

Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Coefficients of variation (COV)1 monthCOVs from 3 measurements of ocular blood flow at visit 1 of observer 1 and at visit 1 of observer 1 and from observer 2 will be computed.
intraclass correlation coefficients (ICCs)1 monthIntraobserver ICC, interobserver ICC, and inter-session ICC will be computed

Secondary

MeasureTime frameDescription
Cofounder1 monthBlood pressure will be checked as potential cofounder

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026