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NCT05353413 Clinical Trial

Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

Optic Neuritis Clinical Trial

Official title:
Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05353413
Other study ID # R-I-002/477/2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date January 1, 2024

Study information
Verified date March 2022
Source Medical University of Bialystok
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Optic neuropathy. Exclusion Criteria: common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Neuroimaging
Magnetic resonance diffusion tensor imaging of the brain
Diagnostic Test:
• VEP - visual evoked potential
Electrophysiology of the visual pathway.
• 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)

Locations
Country Name City State
Poland Lisowski Wasilkow

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Bialystok University of Bialystok

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary sigma parameter sigma parameter in our algorithm provides a quantitative measure of nerve atrophy one month
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