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

Prospective, Non-randomised, Non-controlled Study of 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.

Study Overview

• Status: Completed
• Conditions: Healthy; Open Angle Glaucoma; Normal Tension Glaucoma
• Intervention / Treatment: Diagnostic test: LASER SPECKLE FLOWGRAPHY

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.

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region
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; Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region
healthy controls; individuals with normal optic disc and IOP </21mmHg and normal visual fields	Diagnostic test: LASER SPECKLE FLOWGRAPHY; Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
intraclass correlation coefficients (ICCs)	Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cofounder	Blood pressure will be checked as potential cofounder	1 month
Cofounder	heart rate will be checked as potential cofounder	1 month
Cofounder	spherical equivalent will be checked as potential cofounder	1 month
Cofounder	intraocular pressure will be checked as potential cofounder	1 month

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Cantonal Hosptial Aarau, Department of Ophthalmology, Aarau, Switzerland
• Investigators: Principal Investigator: Marc Töteberg-Harms, MD, FEBO, UniversityHospital Zurich, Department of Ophthalmology, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): February 9, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: glaucoma; retinal blood flow; ocular perfusion pressure
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
• Other Study ID Numbers: LSFG Repro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No