Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

April 28, 2022 updated by: Medical University of Bialystok
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Wasilkow, Poland, 16010
        • Recruiting
        • Lisowski
        • Contact:
          • Lisowski Lukasz, MD
          • Phone Number: +48789194636
          • Email: lisowski@vp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Optic neuropathy.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sigma parameter
Time Frame: one month
sigma parameter in our algorithm provides a quantitative measure of nerve atrophy
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Collaborators

University of Bialystok

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

January 1, 2024

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (ACTUAL)

April 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-I-002/477/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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