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Not yet recruitingNCT07748819DTI & DIRUpdated Aug 6, 2026

DTI & DIR in Optic Neuritis

An observational study in Optic Nerve Disease, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
56
Ages
18 Years and older
Sex
All
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Study summary

To evaluate the role of Double Inversion Recovery (DIR) and Diffusion Tensor Imaging (DTI) in the assessment of optic neuritis and to correlate imaging findings with clinical and visual outcomes.

Read the detailed description

Optic neuritis is an inflammatory demyelinating disorder of the optic nerve that commonly presents with acute visual loss , which can result from a range of causes, making the correct diagnosis and prognosis of distinct conditions important for proper treatment . Optic neuropathies can be either acute or chronic, with acute optic neuropathies having relatively abrupt onsets, while chronic optic neuropathies have a slow and prolonged development .

However, given that ON patients typically recover near-normal vision over time, they are most helpfully analyzed longitudinally, and by comparison between groups based on time of onset. For example, a basic distinction between acute ON representing subjects with recent onset (e.g., no greater than a month) and remote ON representing subjects with at least one episode of ON at least 1 year prior to the current investigation has been reported .

Traditionally, ophthalmologists rely on measurements of the patient's eye and retina, as well as direct tests of their vision to make a diagnosis. In recent years, magnetic resonance imaging (MRI) has become increasingly valuable in analyzing the impacts of optic neuropathies both on and beyond the optic nerve . Visualization and comparison of the downstream impact that optic neuropathies have on pre- and post-geniculate visual pathway regions as well as regions beyond the visual system form a typically untapped addition to standard neuro-ophthalmological assessments .

Nevertheless, the diagnosis of optic nerve affection and consideration of potential differential diagnoses are important in clinical routine. Especially the identification of its distinct pattern can help to differentiate neuromyelitis optica spectrum disease (NMO-SD) and MOG antibody disease (MOG-AD) from MS or other auto inflammatory illnesses. Further consideration of the optic nerves in follow up examinations of MS patients as one potential disease manifestation is reasonable.

Magnetic resonance imaging plays a pivotal role in diagnosis and exclusion of secondary causes. Conventional MRI sequences, including T1-weighted, T2-weighted, and post-contrast imaging, demonstrate optic nerve swelling and enhancement but provide limited quantitative assessment of axonal and myelin integrity.

Diffusion Tensor Imaging (DTI) is an advanced MRI technique that enables in-vivo assessment of white matter microstructure by measuring the directionality and magnitude of water diffusion.

Quantitative DTI parameters such as fractional anisotropy (FA), mean diffusivity (MD), axial diffusivity (AD), and radial diffusivity (RD) reflect axonal damage and demyelination. Traditional anatomical MRI has been extensively used in previous studies to investigate the morphological changes in various brain structures that might accompany disease. The appearance or size of particular grey and white matter regions can be detected and often correlates with important functional and/or clinical variables .

Each voxel in a DTI volume can be represented by an ellipsoid with three principal axes and eigenvectors.The measure along the longest axis which usually runs parallel to the measured axon is referred to as axial diffusivity (AD), while the mean magnitude of flow along the two perpendicular axes is referred to as radial diffusivity (RD). AD and RD measures have shown value in diagnosing axonal damage and myelin damage, respectively .

FA reflects the relative ratio between the anisotropic to isotropic nature of the measured diffusion, with perfectly isotropic diffusion having a value of zero and perfectly anisotropic diffusion having a value of one . An increased MD is commonly associated with damaged tissue because of the resulting increase in free diffusion that this elicits . A relatively high MD can characterize a high level of disorganization, while a low MD represents a highly organized structure .

In contrast, AD and RD values are tied to directional diffusivity and are increasingly representative of microstructural and anatomical details . Nevertheless, it is important to note that these four metrics are not entirely independent: a change in one metric would be expected to affect others .

Several studies have demonstrated alterations in DTI parameters of the optic nerve in optic neuritis; however, the role of DTI in idiopathic optic neuritis remains under-evaluated. This study aims to assess optic nerve microstructural changes using DTI and to correlate imaging findings with clinical and electrophysiological parameters.

In recent years, double inversion recovery (DIR) sequences have been increasingly used. This sequence type uses two different inversion pulses to suppress signals from cerebrospinal fluid (CSF) as well as signals from white matter. This results in a higher lesion-white matter contrast, which improves the detection of cortical lesions and T2-hyperintensities in the infratentorial region specially in MS . Interestingly, lesions of the optic nerves are apparent as well. They revealed the good clinical performance of the DIR in this acute setting. Consequently, we were wondering if DIR sequences are also capable of detecting optic nerve lesions in follow up examinations of optic neuritis patients .

Developing an understanding of how distinct optic neuropathies relate to MRI data metrics can improve the potential for identifying novel biomarkers. This will likely allow for a more integrated and all-encompassing understanding of these conditions with respect to severity, recovery, and treatment.

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Conditions studied

  • Optic Nerve Disease

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03

In context

Optic Nerve Diseases

61 studies on the registry are indexed under Optic Nerve Diseases; 22 are open to participants now.

This study's planned enrollment of 56 is close to the median of 56 across 21 observational studies indexed under Optic Nerve Diseases.

Browse Optic Nerve Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults with clinically suspected optic neuritis referred for MRI evaluation, together with healthy control participants.

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

  • Age above 18 years.
  • Clinically suspected optic neuritis.
  • Evidence of multiple sclerosis or other demyelinating diseases.

Exclusion criteria

Exclusion Criteria:

  • Traumatic optic neuritis.
  • Systemic diseases affecting the optic nerve.
  • to MRI.
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.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy controls

    Twenty-eight healthy volunteers without a history of optic neuritis or other optic nerve disorders. Participants will undergo MRI examination for comparison with the optic neuritis group.

    Device: MRI

  • Optic Neuritis Patients

    Twenty-eight patients diagnosed with optic neuritis who will undergo MRI examination for evaluation of imaging findings.

    Device: MRI

Interventions

  • DeviceMRI

    DTI and DIR

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What researchers measure

Primary outcomes

  1. Fractional anisotropy (FA) value of the affected optic nerve measured by diffusion tensor imaging (DTI)

    Fractional anisotropy (FA) values will be calculated from regions of interest placed along the affected optic nerve and compared between participants with optic neuritis and healthy controls.

    Time frame: Baseline At the time of MRI examination

  2. Mean diffusivity (MD) value of the affected optic nerve measured by diffusion tensor imaging (DTI)

    Mean diffusivity (MD) values will be calculated from regions of interest placed along the affected optic nerve and compared between participants with optic neuritis and healthy controls.

    Time frame: Baseline At Time of MRI examination

Secondary outcomes

  1. Number of optic nerve lesions detected using Double Inversion Recovery MRI.

    The number of optic nerve lesions identified on DIR images will be recorded for each participant.

    Time frame: Baseline At Time of MRI examination

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Li K, Lu C, Huang Y, Yuan L, Zeng D, Wu K. Alteration of fractional anisotropy and mean diffusivity in glaucoma: novel results of a meta-analysis of diffusion tensor imaging studies. PLoS One. 2014 May 14;9(5):e97445. doi: 10.1371/journal.pone.0097445. eCollection 2014. PubMed 24828063 ↗
  • Mendoza M, Shotbolt M, Faiq MA, Parra C, Chan KC. Advanced Diffusion MRI of the Visual System in Glaucoma: From Experimental Animal Models to Humans. Biology (Basel). 2022 Mar 16;11(3):454. doi: 10.3390/biology11030454. PubMed 35336827 ↗
  • Kim JD, Hashemi N, Gelman R, Lee AG. Neuroimaging in ophthalmology. Saudi J Ophthalmol. 2012 Oct;26(4):401-7. doi: 10.1016/j.sjopt.2012.07.001. PubMed 23961025 ↗
  • Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46. PubMed 19668477 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2026; primary completion for Apr 2028, 20 months later.

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

Registered
Jul 1, 2026
First posted
Aug 6, 2026
StartEst.
Aug 1, 2026
Primary completionEst.
Apr 30, 2028
CompletionEst.
Jun 30, 2028
Last update
Aug 6, 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.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07748819
Lead sponsor
Assiut University
Responsible party
Merna youssef nemr (Assistant lecturer, Assiut University) — Principal investigator
First posted
Aug 6, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 6, 2026

Study contacts

Merna Nemr, Assistant lecturer
Contact
monna.merna13@gmail.com
01020731292
Prof.dr afaf Abdkader Hassan, Professor
study chair · Assiut University
Dr omran Khodary Qenway, Assistant professor
study chair · Assiut University
Dr Samaa Mustafa El kossi, Lecturer
study chair · Assiut University
Dr.asmaa Mohamed Mohamed, Lecturer
study chair · Assiut University

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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