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CompletedNCT04014933LSFG ReproUpdated Jun 5, 2023

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

An observational study in Open Angle Glaucoma, Normal Tension Glaucoma and Healthy, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
44
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Open Angle Glaucoma
  • Normal Tension Glaucoma
  • Healthy

Keywords

  • glaucoma
  • retinal blood flow
  • ocular perfusion pressure
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In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's enrollment of 44 is below the median of 100 across 185 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • open-angle glaucoma

    patients with a diagnosis of open-angle glaucoma, i.e. untreated IOP \>21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma

    Diagnostic Test: LASER SPECKLE FLOWGRAPHY

  • normal tension glaucoma

    patients with a diagnosis of normal tension glaucoma, i.e. untreated IOP \</=21mmHg plus glaucomatous disc changes and/or visual field defects typical for glaucoma

    Diagnostic Test: LASER SPECKLE FLOWGRAPHY

  • healthy controls

    individuals with normal optic disc and IOP \</21mmHg and normal visual fields

    Diagnostic Test: LASER SPECKLE FLOWGRAPHY

Interventions

  • Diagnostic testLASER SPECKLE FLOWGRAPHY

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

06

What researchers measure

Primary outcomes

  1. Coefficients of variation (COV)

    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.

    Time frame: 1 month

  2. intraclass correlation coefficients (ICCs)

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

    Time frame: 1 month

Secondary outcomes

  1. Cofounder

    Blood pressure will be checked as potential cofounder

    Time frame: 1 month

  2. Cofounder

    heart rate will be checked as potential cofounder

    Time frame: 1 month

  3. Cofounder

    spherical equivalent will be checked as potential cofounder

    Time frame: 1 month

  4. Cofounder

    intraocular pressure will be checked as potential cofounder

    Time frame: 1 month

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Study locations

1 site
  • Department of Ophthalmology
    Zurich, Canton of Zurich 8091, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Feb 2021, 19 months.

Of 56 observational studies under Glaucoma, Open-Angle, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12. This study's 19 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2019
First posted
Jul 10, 2019
StartActual
Jul 1, 2019
Primary completionActual
Feb 9, 2021
CompletionActual
Dec 31, 2021
Last update
Jun 5, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04014933
Responsible party
Sponsor
First posted
Jul 10, 2019
Start date
Jul 1, 2019
Primary completion
Feb 9, 2021
Completion
Dec 31, 2021
Last update
Jun 5, 2023

Study contacts

Marc Töteberg-Harms, MD, FEBO
principal investigator · UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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