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OpenTrials
Completed

NCT Number: NCT04014933

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LASER SPECKLE FLOWGRAPHY

Diagnostic Test

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

Primary outcomes

  1. Coefficients of variation (COV)

    Time frame: 1 month

    COVs 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.

  2. intraclass correlation coefficients (ICCs)

    Time frame: 1 month

    Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed

Secondary outcomes

  1. Cofounder

    Time frame: 1 month

    Blood pressure will be checked as potential cofounder

  2. Cofounder

    Time frame: 1 month

    heart rate will be checked as potential cofounder

  3. Cofounder

    Time frame: 1 month

    spherical equivalent will be checked as potential cofounder

  4. Cofounder

    Time frame: 1 month

    intraocular pressure will be checked as potential cofounder

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: LSFG Repro

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 10, 2019
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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