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Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

NCT ID: NCT05353413

Last Updated: 2022-04-29

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-01-01

Brief Summary

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The aim of the project is to create a new, non-invasive and safe protocol for the early diagnosis of various types of optic neuropathies with the use of diffusion magnetic resonance imaging

Detailed Description

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In this study, it is planned to find twenty volunteers for each of the neuropathies and twenty healthy volunteers. Each volunteer will undergo clinical tests such as visual acuity, color vision, intraocular pressure measurement, assessment of the anterior chamber and fundus using a slit lamp and Volk lens, macular optical coherence tomography examination and examination of the optic nerve disc (OCT), neurological field vision and visual evoked potential (VEP) testing. Each of the volunteers will undergo magnetic resonance imaging. During active scanning, patients will be asked for not blinking or moving their heads by staring at the red dot on the outside of the camera reflected in the coil mirror. The obtained diffusion tensor data will be used for further analysis.

Conditions

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Ischemic Optic Neuropathy Optic Neuritis Compressive Optic Neuropathy Traumatic Optic Neuropathy Toxic Optic Neuropathy Hereditary Optic Neuropathies

Keywords

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optic neuropathies visual evoked potential

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two groups: volunteers with neuropathies and healthy volunteers
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Various types of optic neuropathies

Patients with various types of optic neuropathy.

Group Type EXPERIMENTAL

Neuroimaging

Intervention Type DEVICE

Magnetic resonance diffusion tensor imaging of the brain

VEP - visual evoked potential

Intervention Type DIAGNOSTIC_TEST

Electrophysiology of the visual pathway.

Ophthalmology examination.

Intervention Type DIAGNOSTIC_TEST

Full ophthalmological examination (visual acuity, color vision, measurement of intraocular pressure, evaluation of the anterior chamber and the fundus of the eye using a slit lamp and the Volk lens, optical coherence tomography examination of the macula and optic nerve disc (OCT), neurological field vision)

Healthy volunteers

Healthy volunteers

Group Type OTHER

Neuroimaging

Intervention Type DEVICE

Magnetic resonance diffusion tensor imaging of the brain

VEP - visual evoked potential

Intervention Type DIAGNOSTIC_TEST

Electrophysiology of the visual pathway.

Ophthalmology examination.

Intervention Type DIAGNOSTIC_TEST

Full ophthalmological examination (visual acuity, color vision, measurement of intraocular pressure, evaluation of the anterior chamber and the fundus of the eye using a slit lamp and the Volk lens, optical coherence tomography examination of the macula and optic nerve disc (OCT), neurological field vision)

Interventions

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Neuroimaging

Magnetic resonance diffusion tensor imaging of the brain

Intervention Type DEVICE

VEP - visual evoked potential

Electrophysiology of the visual pathway.

Intervention Type DIAGNOSTIC_TEST

Ophthalmology examination.

Full ophthalmological examination (visual acuity, color vision, measurement of intraocular pressure, evaluation of the anterior chamber and the fundus of the eye using a slit lamp and the Volk lens, optical coherence tomography examination of the macula and optic nerve disc (OCT), neurological field vision)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Optic neuropathy.

Exclusion Criteria

common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bialystok

OTHER_GOV

Sponsor Role collaborator

Medical University of Bialystok

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lisowski

Wasilków, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Lisowski Lukasz, MD

Role: primary

Other Identifiers

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R-I-002/477/2019

Identifier Type: -

Identifier Source: org_study_id