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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy

NCT03391518

Low Tension Glaucoma

UNKNOWN NA

Investigation of Neurovascular Coupling in Glaucoma Patients and Healthy Subjects

NCT03870230

Glaucoma, Open-Angle Normal Tension Glaucoma Ocular Hypertension

RECRUITING NA

LSFG in Patients With Normal Tension Glaucoma Tension Glaucoma

NCT03318510

Glaucoma, Primary Open Angle

UNKNOWN NA

Evaluation of Blood Flow Characteristics in Glaucoma Using Optical Coherence Tomography Angiography (OCT-A).

NCT02757677

Glaucoma

TERMINATED

Choroidal Blood Flow Response to Hand-grip Test in Progressive Glaucoma

NCT00284440

Primary Open Angle Glaucoma

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Angle Glaucoma Normal Tension Glaucoma Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

LASER SPECKLE FLOWGRAPHY

Intervention Type DIAGNOSTIC_TEST

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

LASER SPECKLE FLOWGRAPHY

Intervention Type DIAGNOSTIC_TEST

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

LASER SPECKLE FLOWGRAPHY

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LASER SPECKLE FLOWGRAPHY

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes