Optic Nerve DiseaseDTI & DIRNCT07748819
DTI & DIR in Optic Neuritis
An observational study of Optic Nerve Disease, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optic Nerve Disease
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Adults with clinically suspected optic neuritis referred for MRI evaluation, together with healthy control participants.
Who may be able to join
- Age above 18 years.
- Clinically suspected optic neuritis.
- Evidence of multiple sclerosis or other demyelinating diseases.
Who cannot join
- Traumatic optic neuritis.
- Systemic diseases affecting the optic nerve.
- Contraindications to MRI.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: MRI Evaluation of Optic Neuritis : Integrating Double Inversion Recovery and Diffusion Tensor Imaging .
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.
- Conditions
- Optic Nerve Disease
- Being tested
- MRI
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
DTI and DIR
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MRI | |
| Optic Neuritis Patients | Twenty-eight patients diagnosed with optic neuritis who will undergo MRI examination for evaluation of imaging findings. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline At the time of MRI examination
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.
Measured: 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.
Measured: Baseline At Time of MRI examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Optic Nerve DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merna youssef nemr, Assiut University
- Investigators
- Prof.dr afaf Abdkader Hassan, Professor, Study chair, Assiut UniversityDr omran Khodary Qenway, Assistant professor, Study chair, Assiut UniversityDr Samaa Mustafa El kossi, Lecturer, Study chair, Assiut UniversityDr.asmaa Mohamed Mohamed, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748819
- Sponsor's protocol ID
- MRI in optic neuritis
- Acronym
- DTI & DIR
- Status last verified
- May 2026
- First submitted
- 1 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24828063Mendoza 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 35336827Kim 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 23961025Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.
PubMed 19668477
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Evaluation of Optic Neuritis : Integrating Double Inversion Recovery and Diffusion Tensor Imaging .
- ClinicalTrials.gov ID
- NCT07748819
- Acronym / sponsor ID
- DTI & DIR / MRI in optic neuritis
- Conditions
- Optic Nerve Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Aug 2026 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Device: MRITwenty-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. |
| Optic Neuritis Patients | – | Device: MRITwenty-eight patients diagnosed with optic neuritis who will undergo MRI examination for evaluation of imaging findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with clinically suspected optic neuritis referred for MRI evaluation, together with healthy control participants.
Key inclusion criteria (3 listed)
- Age above 18 years.
- Clinically suspected optic neuritis.
- Evidence of multiple sclerosis or other demyelinating diseases.
Key exclusion criteria (3 listed)
- Traumatic optic neuritis.
- Systemic diseases affecting the optic nerve.
- Contraindications to MRI.
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 |
|---|---|---|
| MRIDTI and DIR | Device | Healthy controls, Optic Neuritis Patients |
Primary outcome
Fractional anisotropy (FA) value of the affected optic nerve measured by diffusion tensor imaging (DTI)
Time frame: Baseline At the time of MRI examination
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.
Mean diffusivity (MD) value of the affected optic nerve measured by diffusion tensor imaging (DTI)
Time frame: Baseline At Time of MRI examination
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.
1 secondary outcome
Number of optic nerve lesions detected using Double Inversion Recovery MRI.
Time frame: Baseline At Time of MRI examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 24828063Li 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.
- Background: PubMed 35336827Mendoza 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.
- Background: PubMed 23961025Kim 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.
- Background: PubMed 19668477Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.
- 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.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Nerve Disease, run by Assiut University.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merna Nemr, Assistant lecturer (01020731292, monna.merna13@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy (FA) value of the affected optic nerve measured by diffusion tensor imaging (DTI) (time frame: Baseline At the time of MRI examination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07748819, which also lists 4 linked publications.
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 6 Aug 2026.