Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

Sponsor

Medical University of Bialystok (Other)

Overall Status

Recruiting

CT.gov ID

NCT05353413

Collaborator

University of Bialystok (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Ischemic Optic Neuropathy Optic Neuritis Compressive Optic Neuropathy Traumatic Optic Neuropathy Toxic Optic Neuropathy Hereditary Optic Neuropathies	Device: Neuroimaging Diagnostic Test: VEP - visual evoked potential Diagnostic Test: Ophthalmology examination.	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Two groups: volunteers with neuropathies and healthy volunteersTwo groups: volunteers with neuropathies and healthy volunteers

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

Actual Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Various types of optic neuropathies Patients with various types of optic neuropathy.	Device: Neuroimaging Magnetic resonance diffusion tensor imaging of the brain Diagnostic Test: VEP - visual evoked potential Electrophysiology of the visual pathway. 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)
Other: Healthy volunteers Healthy volunteers	Device: Neuroimaging Magnetic resonance diffusion tensor imaging of the brain Diagnostic Test: VEP - visual evoked potential Electrophysiology of the visual pathway. 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)

Arm

Intervention/Treatment

Experimental: Various types of optic neuropathies

Patients with various types of optic neuropathy.

Device: Neuroimaging

Magnetic resonance diffusion tensor imaging of the brain

Diagnostic Test: VEP - visual evoked potential

Electrophysiology of the visual pathway.

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)

Other: Healthy volunteers

Healthy volunteers

Device: Neuroimaging

Magnetic resonance diffusion tensor imaging of the brain

Diagnostic Test: VEP - visual evoked potential

Electrophysiology of the visual pathway.

Diagnostic Test: Ophthalmology examination.

Outcome Measures

Primary Outcome Measures

sigma parameter [one month]
sigma parameter in our algorithm provides a quantitative measure of nerve atrophy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Optic neuropathy.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lisowski	Wasilkow		Poland	16010

Sponsors and Collaborators

Medical University of Bialystok
University of Bialystok

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Bialystok

ClinicalTrials.gov Identifier:

NCT05353413

Other Study ID Numbers:

R-I-002/477/2019

First Posted:

Apr 29, 2022

Last Update Posted:

Apr 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Bialystok

optic neuropathies

visual evoked potential

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Optic Nerve Diseases

Neuritis

Optic Neuritis

Optic Neuropathy, Ischemic

Optic Nerve Injuries

Toxic Optic Neuropathy

Study Results

No Results Posted as of Apr 29, 2022