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

Healthy Clinical Trial

— LSFG Repro  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04014933
• Other study ID #: LSFG Repro
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 31, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Healthy
• Low Tension Glaucoma
• Normal Tension Glaucoma
• Open Angle Glaucoma

Intervention

Diagnostic Test:
• LASER SPECKLE FLOWGRAPHY
Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	intraclass correlation coefficients (ICCs)	Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed	1 month
Secondary	Cofounder	Blood pressure will be checked as potential cofounder	1 month
Secondary	Cofounder	heart rate will be checked as potential cofounder	1 month
Secondary	Cofounder	spherical equivalent will be checked as potential cofounder	1 month
Secondary	Cofounder	intraocular pressure will be checked as potential cofounder	1 month