Ischemic Optic NeuropathyNCT05353413
Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.
A study testing Neuroimaging, VEP - visual evoked potential and Ophthalmology examination. in people with Ischemic Optic Neuropathy and Optic Neuritis, run by Medical University of Bialystok at 1 site in Poland.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Optic Neuropathy, Optic Neuritis, Compressive Optic Neuropathy
- What is being tested?
- Neuroimaging, VEP - visual evoked potential and Ophthalmology examination.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2020to 6 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient group: optic neuropathy.
- Planned healthy control group: healthy volunteers without concomitant diseases.
Who cannot join
- Common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia).
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Original planned protocol:
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.
Actual study conduct:
The study was terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled. All participant measurements, including those for the primary outcome, were completed on March 6, 2026. Data analysis continued after the completion of participant measurements.
- Conditions
- Ischemic Optic Neuropathy, Optic Neuritis, Compressive Optic Neuropathy, Traumatic Optic Neuropathy, Toxic Optic Neuropathy, Hereditary Optic Neuropathies
- Being tested
- Neuroimaging, VEP - visual evoked potential, Ophthalmology examination.
- Keywords
- optic neuropathies, visual evoked potential
- Medical subject headings
- Optic Neuropathy, Ischemic, Optic Neuritis, Optic Nerve Injuries, Toxic Optic Neuropathy, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroimagingDevice
Magnetic resonance diffusion tensor imaging of the brain
VEP - visual evoked potentialDiagnostic test
Electrophysiology of the visual pathway.
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)
| Study group | Role | What they receive |
|---|---|---|
| Various types of optic neuropathies | Experimental | Patients with various types of optic neuropathy. Receives: Device: Neuroimaging; Diagnostic Test: VEP - visual evoked potential; Diagnostic Test: Ophthalmology examination. |
| Healthy volunteers | Other | Healthy volunteers Receives: Device: Neuroimaging; Diagnostic Test: VEP - visual evoked potential; Diagnostic Test: Ophthalmology examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sigma parameter
sigma parameter in our algorithm provides a quantitative measure of nerve atrophy
Measured: Periprocedural (single MRI examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Jan 2020
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Why it stopped: Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel groups were planned: patients with optic neuropathies and healthy volunteers as a separate control group. Both groups were to undergo the same diagnostic procedures, without random allocation. Seven patients were enrolled; no healthy volunteers were enrolled before the study was terminated.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bialystok
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353413
- Sponsor's protocol ID
- R-I-002/477/2019
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.
- ClinicalTrials.gov ID
- NCT05353413
- Acronym / sponsor ID
- R-I-002/477/2019
- Conditions
- Ischemic Optic Neuropathy, Optic Neuritis, Compressive Optic Neuropathy, Traumatic Optic Neuropathy, Toxic Optic Neuropathy, Hereditary Optic Neuropathies
- Keywords
- optic neuropathies, visual evoked potential
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Collaborators
- University of Bialystok
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Original planned protocol:
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.
Actual study conduct:
The study was terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled. All participant measurements, including those for the primary outcome, were completed on March 6, 2026. Data analysis continued after the completion of participant measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups were planned: patients with optic neuropathies and healthy volunteers as a separate control group. Both groups were to undergo the same diagnostic procedures, without random allocation. Seven patients were enrolled; no healthy volunteers were enrolled before the study was terminated.
| Arm | Type | Receives |
|---|---|---|
| Various types of optic neuropathies | Experimental | Device: Neuroimaging, Diagnostic Test: VEP - visual evoked potential, Diagnostic Test: Ophthalmology examination.Patients with various types of optic neuropathy. |
| Healthy volunteers | Other | Device: Neuroimaging, Diagnostic Test: VEP - visual evoked potential, Diagnostic Test: Ophthalmology examination.Healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient group: optic neuropathy.
- Planned healthy control group: healthy volunteers without concomitant diseases.
Key exclusion criteria (1 listed)
- Common contraindications to MRI (presence of pacemaker, non-MRI-safety or claustrophobia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroimagingMagnetic resonance diffusion tensor imaging of the brain | Device | Healthy volunteers, Various types of optic neuropathies |
| VEP - visual evoked potentialElectrophysiology of the visual pathway. | Diagnostic test | Healthy volunteers, Various types of optic neuropathies |
| 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) | Diagnostic test | Healthy volunteers, Various types of optic neuropathies |
Primary outcome
sigma parameter
Time frame: Periprocedural (single MRI examination)
sigma parameter in our algorithm provides a quantitative measure of nerve atrophy
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroimaging, VEP - visual evoked potential and Ophthalmology examination. in people with Ischemic Optic Neuropathy and Optic Neuritis, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sigma parameter (time frame: Periprocedural (single MRI examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.