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

Sponsor

University of Zurich (Other)

Overall Status

Unknown status

CT.gov ID

NCT04014933

Collaborator

Cantonal Hosptial Aarau, Department of Ophthalmology, Aarau, Switzerland (Other)

150

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma Normal Tension Glaucoma Healthy	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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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

Actual Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Feb 9, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Coefficients of variation (COV) [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.
intraclass correlation coefficients (ICCs) [1 month]
Intraobserver ICC, interobserver ICC, and inter-session ICC will be computed

Secondary Outcome Measures

Cofounder [1 month]
Blood pressure will be checked as potential cofounder
Cofounder [1 month]
heart rate will be checked as potential cofounder
Cofounder [1 month]
spherical equivalent will be checked as potential cofounder
Cofounder [1 month]
intraocular pressure will be checked as potential cofounder

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.