ClinicalTrials.gg
TerminatedNCT05353413Updated Oct 23, 2026

Diffusion Weighted Magnetic Resonance Imaging and the Optic Nerve Neuropathy.

An interventional study of Neuroimaging and VEP - visual evoked potential in Ischemic Optic Neuropathy, Optic Neuritis and Compressive Optic Neuropathy, sponsored by Medical University of Bialystok. Terminated at 1 site in Poland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Medical University of Bialystok · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2020, registered Mar 2022).
Updated Oct 23, 2026Now TerminatedPrimary completion moved+6 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

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

Keywords

  • optic neuropathies
  • visual evoked potential
03

In context

Optic Neuropathy, Ischemic

55 studies on the registry are indexed under Optic Neuropathy, Ischemic; 11 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 35 interventional studies indexed under Optic Neuropathy, Ischemic.

Browse Optic Neuropathy, Ischemic studies →

Lead sponsor

Medical University of Bialystok is the lead sponsor of 72 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 23, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient group: optic neuropathy.
  • Planned healthy control group: healthy volunteers without concomitant diseases.

Exclusion criteria

Exclusion Criteria:

- Common to MRI (presence of pacemaker, non-MRI-safety or claustrophobia).

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Various types of optic neuropathies

    Patients with various types of optic neuropathy.

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

  • Other
    Healthy volunteers

    Healthy volunteers

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

Interventions

  • DeviceNeuroimaging

    Magnetic resonance diffusion tensor imaging of the brain

  • Diagnostic testVEP - visual evoked potential

    Electrophysiology of the visual pathway.

  • Diagnostic testOphthalmology 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)

06

What researchers measure

Primary outcomes

  1. sigma parameter

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

    Time frame: Periprocedural (single MRI examination)

07

Study locations

1 site
  • Lisowski
    Sobolewo, 15509, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jan 2020 to primary completion in Mar 2026, 74 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 23, 2026: primary completion Jan 2024 → Mar 2026 and completion Jan 2024 → Mar 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2022
First posted
Apr 29, 2022
StartActual
Jan 1, 2020
Primary completionActual
Mar 6, 2026was Jan 2024
CompletionActual
Mar 6, 2026was Jan 2024
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Terminated Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.
changed Oct 23, 2026
Sites
1 site added, 1 site removed
Show site
  • Lisowski · Sobolewo, Poland
Show 1 removed
  • Lisowski · Wasilkow, Poland
Oct 23, 2026
Primary completion
Jan 1, 2024→Mar 6, 2026 (actual)
Oct 23, 2026
Study completion
Jan 1, 2024→Mar 6, 2026 (actual)
Oct 23, 2026
Enrollment
20 (estimated)→7 (actual)
Oct 23, 2026
Eligibility
1 inclusion criterion edited, 1 added
What changed in the criteria
Inclusion criteria
  • EditedOpticPatient group: optic neuropathy.
  • AddedPlanned healthy control group: healthy volunteers without concomitant diseases.
Oct 23, 2026
Primary outcomes
1 time frame changed
What changed in the outcomes
  • Time framesigma parameterone month → Periprocedural (single MRI examination)
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Status unknown→Terminated
    Why stopped Study terminated prematurely due to lack of funding. Seven patients with optic neuropathies were enrolled; no healthy volunteers were enrolled.
    1 site added, 1 site removed
    Show site
    • Lisowski · Sobolewo, Poland
    Show 1 removed
    • Lisowski · Wasilkow, Poland
    Primary completion Jan 1, 2024→Mar 6, 2026 (now actual)
    Study completion Jan 1, 2024→Mar 6, 2026 (now actual)
    Enrollment 20 (estimated)→7 (actual)
    Eligibility 1 inclusion criterion edited, 1 added
    What changed in the criteria
    Inclusion criteria
    • EditedOpticPatient group: optic neuropathy.
    • AddedPlanned healthy control group: healthy volunteers without concomitant diseases.
    Primary outcomes 1 time frame changed
    What changed in the outcomes
    • Time framesigma parameterone month → Periprocedural (single MRI examination)
    + 3 other changes: description, design details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05353413
Lead sponsor
Medical University of Bialystok
Collaborators
University of Bialystok
Responsible party
Sponsor
First posted
Apr 29, 2022
Start date
Jan 1, 2020
Primary completion
Mar 6, 2026
Completion
Mar 6, 2026
Last update
Oct 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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