Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

NCT05353413 | Unknown

• 1 other identifier: R-I-002/477/2019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

optic neuropathies; visual evoked potential

Outcome Measures

Primary Outcomes (1)

• sigma parameter

  sigma parameter in our algorithm provides a quantitative measure of nerve atrophy

  one month

Study Arms (2)

Various types of optic neuropathies

EXPERIMENTAL

Patients with various types of optic neuropathy.

Device: Neuroimaging; Diagnostic Test: VEP - visual evoked potential; Diagnostic Test: Ophthalmology examination.

Healthy volunteers

OTHER

Healthy volunteers

Device: Neuroimaging; Diagnostic Test: VEP - visual evoked potential; Diagnostic Test: Ophthalmology examination.

Interventions

Neuroimaging DEVICE

Magnetic resonance diffusion tensor imaging of the brain

Healthy volunteers; Various types of optic neuropathies

VEP - visual evoked potential DIAGNOSTIC_TEST

Electrophysiology of the visual pathway.

Healthy volunteers; Various types of optic neuropathies

Ophthalmology examination. 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; Various types of optic neuropathies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Optic neuropathy.

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Bialystok: lead
• University of Bialystok: collaborator

Study Sites (1)

Lisowski

Wasilków, 16010, Poland

RECRUITING

MeSH Terms

Conditions

Optic Neuropathy, Ischemic; Optic Neuritis; Optic Nerve Injuries; Toxic Optic Neuropathy; Optic Nerve Diseases

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups: volunteers with neuropathies and healthy volunteers

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 29, 2022
• Study Start: January 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)