Clinical Trials Logo

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


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
See also
  Status Clinical Trial Phase
Unknown status NCT00261326 - Simvastatin Treatment of Patients With Acute Optic Neuritis Phase 3
Active, not recruiting NCT03963310 - Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis
Recruiting NCT03586557 - Effectiveness of Plasma Exchange in Treating With Severe Acute AQP4-Ab Positive Optic Neuritis N/A
Recruiting NCT05487989 - VIsual Pathways Model in Neuro-inflammatory Disorders
Terminated NCT04131764 - Diagnosis of ON With or Without MS or NMOSD
Not yet recruiting NCT06453694 - Efgartigimod for the Treatment of Acute Optic Neuritis Phase 2
Completed NCT01962571 - Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial Phase 3
Recruiting NCT03302585 - High-Dose Vitamin D Induction in Optic Neuritis Phase 2
Recruiting NCT02886377 - The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset N/A
Completed NCT01987167 - Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis Early Phase 1
Completed NCT01451593 - Neuroprotection With Phenytoin in Optic Neuritis Phase 2
Completed NCT03630497 - BN201 SAD MAD Study in Healthy Subjects Phase 1
Completed NCT01337986 - Ampyra for Optic Neuritis in Multiple Sclerosis Phase 2/Phase 3
Completed NCT01274702 - Visual Reconstitution Therapy After Optic Neuritis Phase 2
Active, not recruiting NCT00445367 - Biobank For MS And Other Demyelinating Diseases
Withdrawn NCT00037115 - Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event. Phase 4
Not yet recruiting NCT06389968 - Light Stimulation to Improve Visual Function After Optic Neuritis in Persons With Multiple Sclerosis N/A
Recruiting NCT04257734 - Epidemiologic and Clinical Characteristics of Optic Neuritis in China
Completed NCT03753893 - Ocular Manifestations in Rheumatic Diseases
Completed NCT02939937 - Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis Phase 2