Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.
Primary Purpose
Ischemic Optic Neuropathy, Optic Neuritis, Compressive Optic Neuropathy
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Neuroimaging
VEP - visual evoked potential
Ophthalmology examination.
Sponsored by
About this trial
This is an interventional diagnostic trial for Ischemic Optic Neuropathy focused on measuring optic neuropathies, visual evoked potential
Eligibility Criteria
Inclusion Criteria:
Optic neuropathy.
Exclusion Criteria:
common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia)
Sites / Locations
- LisowskiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Various types of optic neuropathies
Healthy volunteers
Arm Description
Patients with various types of optic neuropathy.
Healthy volunteers
Outcomes
Primary Outcome Measures
sigma parameter
sigma parameter in our algorithm provides a quantitative measure of nerve atrophy
Secondary Outcome Measures
Full Information
NCT ID
NCT05353413
First Posted
March 16, 2022
Last Updated
April 28, 2022
Sponsor
Medical University of Bialystok
Collaborators
University of Bialystok
1. Study Identification
Unique Protocol Identification Number
NCT05353413
Brief Title
Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.
Official Title
Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Bialystok
Collaborators
University of Bialystok
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Optic Neuropathy, Optic Neuritis, Compressive Optic Neuropathy, Traumatic Optic Neuropathy, Toxic Optic Neuropathy, Hereditary Optic Neuropathies
Keywords
optic neuropathies, visual evoked potential
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Two groups: volunteers with neuropathies and healthy volunteers
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Various types of optic neuropathies
Arm Type
Experimental
Arm Description
Patients with various types of optic neuropathy.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers
Intervention Type
Device
Intervention Name(s)
Neuroimaging
Intervention Description
Magnetic resonance diffusion tensor imaging of the brain
Intervention Type
Diagnostic Test
Intervention Name(s)
VEP - visual evoked potential
Intervention Description
Electrophysiology of the visual pathway.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ophthalmology examination.
Intervention Description
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)
Primary Outcome Measure Information:
Title
sigma parameter
Description
sigma parameter in our algorithm provides a quantitative measure of nerve atrophy
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Optic neuropathy.
Exclusion Criteria:
common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia)
Facility Information:
Facility Name
Lisowski
City
Wasilkow
ZIP/Postal Code
16010
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisowski Lukasz, MD
Phone
+48789194636
Email
lisowski@vp.pl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.
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