NCT07748819

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
23mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Jun 2028

First Submitted

Initial submission to the registry

July 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.7 years

First QC Date

July 1, 2026

Last Update Submit

July 31, 2026

Conditions

Optic Nerve Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline At Time of MRI examination

Secondary Outcomes (1)

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

    Baseline At Time of MRI examination

Study Arms (2)

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

MRIDEVICE

DTI and DIR

Healthy controlsOptic Neuritis Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 24828063BACKGROUND

  • 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.

    PMID: 35336827BACKGROUND

  • 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.

    PMID: 23961025BACKGROUND

  • Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.

    PMID: 19668477BACKGROUND

MeSH Terms

Conditions

Optic Nerve Diseases

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Prof.dr afaf Abdkader Hassan, Professor

    Assiut University

    STUDY CHAIR

  • Dr omran Khodary Qenway, Assistant professor

    Assiut University

    STUDY CHAIR

  • Dr Samaa Mustafa El kossi, Lecturer

    Assiut University

    STUDY CHAIR

  • Dr.asmaa Mohamed Mohamed, Lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Merna Nemr, Assistant lecturer

CONTACT

01020731292monna.merna13@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

July 1, 2026

First Posted

August 6, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

August 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share