Multiple SclerosisMSNCT07175324
Oct-A and Perimetry in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Assiut University.
Trial summary
This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field changes in MS patients with and without a history of ON Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- optical coherence tomography angiography and Visual Field Perimetry
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with multiple sclerosis and healthy control group in Assiut
Who may be able to join
- Diagnosis of relapsing-remitting multiple sclerosis (RR-MS) or other MS subtypes confirmed by established neurological criteria. .Ability to undergo OCTA imaging and visual field testing. .Visual acuity sufficient to perform reliable visual field testing.
- Absence of other ocular diseases affecting the retina or optic nerve (e.g., diabetic retinopathy, glaucoma)
Who cannot join
- .History of ocular diseases unrelated to MS that could confound OCTA or visual field results.
- .Recent optic neuritis episode within a defined period (often 3-6 months) to avoid acute inflammation effects.
- .Media opacities preventing quality OCTA imaging. .Systemic diseases that may affect retinal vasculature (e.g., uncontrolled hypertension, diabetes).
- .Poor cooperation or inability to complete visual field testing reliably
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: Correlation Between Optical Coherence Tomography Angiography and Visual Field Changes in Patients With Multiple Sclerosis
This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field changes in MS patients with and without a history of ON
Read the detailed description
The aim of this work is to investigate the correlation between visual field parameters and optical coherence tomography angiography (OCT-A) findings in patients with multiple sclerosis (MS). MS is a chronic autoimmune demyelinating disease that frequently involves the visual pathway, often presenting with optic neuritis (ON) and subsequent neurodegeneration. OCT-A, a non-invasive imaging modality, enables detailed visualization and quantification of retinal microvasculature, particularly the superficial and deep capillary plexuses, which supply the retinal ganglion cells and nerve fiber layers. Previous studies have demonstrated reduced retinal vessel density and thinning of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) in MS patients, reflecting neuro-axonal damage and microvascular impairment. However, the relationship between these structural and vascular changes and functional visual outcomes, such as visual field loss, remains to be fully elucidated.
This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field indices in MS patients with and without a history of ON. By analyzing inter-eye differences and comparing with MS patients, the research seeks to clarify whether OCT-A metrics can serve as reliable biomarkers for visual dysfunction and disease progression in MS. Understanding this correlation could improve early detection of neuroretinal damage, guide monitoring of disease activity, and potentially inform therapeutic strategies.
- Conditions
- Multiple Sclerosis
- Being tested
- optical coherence tomography angiography, Visual Field Perimetry
- Keywords
- MS, OctA
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optical coherence tomography angiographyDevice
correlation between OctA and Visual field changes in Multiple Sclerosis
Visual Field PerimetryDevice
Correlation between OctA and Visual field changes in Multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| patients with multiple sclerosis | Not described Receives: Device: optical coherence tomography angiography; Device: Visual Field Perimetry | |
| healthy control | Not described Receives: Device: optical coherence tomography angiography; Device: Visual Field Perimetry |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-To evaluate the correlation between OCTA-derived microvascular metrics {Structural measure} and visual field defects{Functional measure} in patients with multiple sclerosis (MS)
The aim of this work is to investigate the correlation between visual field parameters and optical coherence tomography angiography (OCT-A) findings in patients with multiple sclerosis (MS). MS is a chronic autoimmune demyelinating disease that frequently involves the visual pathway, often presenting with optic neuritis (ON) and subsequent neurodegeneration. OCT-A, a non-invasive imaging modality, enables detailed visualization and quantification of retinal microvasculature, particularly the superficial and deep capillary plexuses, which supply the retinal ganglion cells and nerve fiber layers. Previous studies have demonstrated reduced retinal vessel density and thinning of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) in MS patients, reflecting neuro-axonal damage and microvascular impairment. However, the correlation between these structural and vascular changes and functional visual outcomes, such as visual field loss, remains to be fully elucidated.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (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 Multiple SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Gamal Nouby Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175324
- Sponsor's protocol ID
- OctA in Multiple sclerosis
- Acronym
- MS
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mancino, R., Martucci, A., Di Costanzo, A., et al. (2021).Optical coherence tomography and optical coherence tomography angiography findings in multiple sclerosis patientshttps://www.tandfonline.com/doi/full/10.1080/01658107.2021.1963787
Liu J, Song S, Gu X, Li H, Yu X. Microvascular impairments detected by optical coherence tomography angiography in multiple sclerosis patients: A systematic review and meta-analysis. Front Neurosci. 2023 Jan 13;16:1121899. doi: 10.3389/fnins.2022.1121899. eCollection 2022.
PubMed 36711144Farci R, Carta A, Cocco E, Frau J, Fossarello M, Diaz G. Optical coherence tomography angiography in multiple sclerosis: A cross-sectional study. PLoS One. 2020 Jul 23;15(7):e0236090. doi: 10.1371/journal.pone.0236090. eCollection 2020.
PubMed 32702050Mohammadi S, Gouravani M, Salehi MA, Arevalo JF, Galetta SL, Harandi H, Frohman EM, Frohman TC, Saidha S, Sattarnezhad N, Paul F. Optical coherence tomography angiography measurements in multiple sclerosis: a systematic review and meta-analysis. J Neuroinflammation. 2023 Mar 27;20(1):85. doi: 10.1186/s12974-023-02763-4.
PubMed 36973708
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Optical Coherence Tomography Angiography and Visual Field Changes in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07175324
- Acronym / sponsor ID
- MS / OctA in Multiple sclerosis
- Conditions
- Multiple Sclerosis
- Keywords
- MS, OctA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field changes in MS patients with and without a history of ON
Detailed description
The aim of this work is to investigate the correlation between visual field parameters and optical coherence tomography angiography (OCT-A) findings in patients with multiple sclerosis (MS). MS is a chronic autoimmune demyelinating disease that frequently involves the visual pathway, often presenting with optic neuritis (ON) and subsequent neurodegeneration. OCT-A, a non-invasive imaging modality, enables detailed visualization and quantification of retinal microvasculature, particularly the superficial and deep capillary plexuses, which supply the retinal ganglion cells and nerve fiber layers. Previous studies have demonstrated reduced retinal vessel density and thinning of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) in MS patients, reflecting neuro-axonal damage and microvascular impairment. However, the relationship between these structural and vascular changes and functional visual outcomes, such as visual field loss, remains to be fully elucidated.
This study aims to assess retinal vascular density using OCT-A and correlate these parameters with visual field indices in MS patients with and without a history of ON. By analyzing inter-eye differences and comparing with MS patients, the research seeks to clarify whether OCT-A metrics can serve as reliable biomarkers for visual dysfunction and disease progression in MS. Understanding this correlation could improve early detection of neuroretinal damage, guide monitoring of disease activity, and potentially inform therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with multiple sclerosis | – | Device: optical coherence tomography angiography, Device: Visual Field Perimetry |
| healthy control | – | Device: optical coherence tomography angiography, Device: Visual Field Perimetry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with multiple sclerosis and healthy control group in Assiut
Key inclusion criteria (2 listed)
- Diagnosis of relapsing-remitting multiple sclerosis (RR-MS) or other MS subtypes confirmed by established neurological criteria. .Ability to undergo OCTA imaging and visual field testing. .Visual acuity sufficient to perform reliable visual field testing.
- Absence of other ocular diseases affecting the retina or optic nerve (e.g., diabetic retinopathy, glaucoma)
Key exclusion criteria (4 listed)
- .History of ocular diseases unrelated to MS that could confound OCTA or visual field results.
- .Recent optic neuritis episode within a defined period (often 3-6 months) to avoid acute inflammation effects.
- .Media opacities preventing quality OCTA imaging. .Systemic diseases that may affect retinal vasculature (e.g., uncontrolled hypertension, diabetes).
- .Poor cooperation or inability to complete visual field testing reliably
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 |
|---|---|---|
| optical coherence tomography angiographycorrelation between OctA and Visual field changes in Multiple Sclerosis | Device | healthy control, patients with multiple sclerosis |
| Visual Field PerimetryCorrelation between OctA and Visual field changes in Multiple sclerosis | Device | healthy control, patients with multiple sclerosis |
Primary outcome
1-To evaluate the correlation between OCTA-derived microvascular metrics {Structural measure} and visual field defects{Functional measure} in patients with multiple sclerosis (MS)
Time frame: baseline
The aim of this work is to investigate the correlation between visual field parameters and optical coherence tomography angiography (OCT-A) findings in patients with multiple sclerosis (MS). MS is a chronic autoimmune demyelinating disease that frequently involves the visual pathway, often presenting with optic neuritis (ON) and subsequent neurodegeneration. OCT-A, a non-invasive imaging modality, enables detailed visualization and quantification of retinal microvasculature, particularly the superficial and deep capillary plexuses, which supply the retinal ganglion cells and nerve fiber layers. Previous studies have demonstrated reduced retinal vessel density and thinning of retinal nerve fiber layer (RNFL) and ganglion cell complex (GCC) in MS patients, reflecting neuro-axonal damage and microvascular impairment. However, the correlation between these structural and vascular changes and functional visual outcomes, such as visual field loss, remains to be fully elucidated.
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 16 Sep 2025.
- Results publicationMancino, R., Martucci, A., Di Costanzo, A., et al. (2021).Optical coherence tomography and optical coherence tomography angiography findings in multiple sclerosis patientshttps://www.tandfonline.com/doi/full/10.1080/01658107.2021.1963787
- Results publication: PubMed 36711144Liu J, Song S, Gu X, Li H, Yu X. Microvascular impairments detected by optical coherence tomography angiography in multiple sclerosis patients: A systematic review and meta-analysis. Front Neurosci. 2023 Jan 13;16:1121899. doi: 10.3389/fnins.2022.1121899. eCollection 2022.
- Results publication: PubMed 32702050Farci R, Carta A, Cocco E, Frau J, Fossarello M, Diaz G. Optical coherence tomography angiography in multiple sclerosis: A cross-sectional study. PLoS One. 2020 Jul 23;15(7):e0236090. doi: 10.1371/journal.pone.0236090. eCollection 2020.
- Results publication: PubMed 36973708Mohammadi S, Gouravani M, Salehi MA, Arevalo JF, Galetta SL, Harandi H, Frohman EM, Frohman TC, Saidha S, Sattarnezhad N, Paul F. Optical coherence tomography angiography measurements in multiple sclerosis: a systematic review and meta-analysis. J Neuroinflammation. 2023 Mar 27;20(1):85. doi: 10.1186/s12974-023-02763-4.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, 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 2 inclusion and 4 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 16 Sep 2025. 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 Omar Gamal Nouby, resident doctor (+0201124142020, omar.17289573@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-To evaluate the correlation between OCTA-derived microvascular metrics {Structural measure} and visual field defects{Functional measure} in patients with multiple sclerosis (MS) (time frame: baseline). 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 NCT07175324, 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 16 Sep 2025.