Meibomian Gland DysfunctionNCT07810569
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
An observational study of Meibomian Gland Dysfunction and Dry Eye Syndromes, run by Assiut University.
Trial summary
This observational study aims to assess the frequency and severity of Meibomian Gland Dysfunction (MGD) and associated ocular surface changes in patients with systemic autoimmune rheumatic diseases compared with healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye Syndromes, Rheumatoid Arthritis
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- 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
- Adult, Older adult
Study population: Adult patients attending outpatient rheumatology services at Assiut University and Al-Azhar University with confirmed diagnoses of systemic autoimmune rheumatic diseases (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, or Psoriatic Arthritis), alongside age- and sex-matched healthy control volunteers from the same geographic region with no systemic autoimmune disease or active ocular surface complaints.
Who may be able to join
- Age 18 years or older
- Ability to provide written informed consent
- For rheumatologic patients: Confirmed clinical diagnosis of one of the following autoimmune diseases:
- Rheumatoid Arthritis (2010 ACR/EULAR classification criteria)
- Systemic Lupus Erythematosus (2019 EULAR/ACR classification criteria)
- Sjogren's Syndrome (2016 ACR/EULAR classification criteria)
Show all 9Show fewer
- Ankylosing Spondylitis (modified New York criteria)
- Psoriatic Arthritis (CASPAR criteria)
- For healthy controls: Age- and sex-matched individuals with no systemic autoimmune disease and no current ocular surface complaints
Who cannot join
- Chronic use of topical antiglaucoma eye drops
- Ocular surgery within the past 6 months
- Active ocular infection or active uveitis
- Contact lens wearers who have not discontinued wear for at least 2 weeks
- History of ocular chemical burns
- Pregnancy or lactation
- Incomplete rheumatologic records or missing essential laboratory data
About this study
Official title: Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients: A Cross-Sectional Analytical Study
This observational study aims to assess the frequency and severity of Meibomian Gland Dysfunction (MGD) and associated ocular surface changes in patients with systemic autoimmune rheumatic diseases compared with healthy volunteers.
Meibomian glands are specialized glands in the eyelids that produce the lipid layer of tears, preventing tear evaporation. Systemic inflammation in rheumatologic conditions may affect these glands, leading to dry eye symptoms and ocular surface damage.
Read more
A total of 150 participants (120 rheumatologic patients and 30 healthy controls) will be evaluated in a single cross-sectional examination. Rheumatologic diagnoses include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, and Psoriatic Arthritis.
Participants will undergo a standardized series of non-invasive and minimally invasive eye examinations, including:
- An ocular symptom questionnaire (Ocular Surface Disease Index)
- Non-contact infrared meibography to assess meibomian gland loss (Meiboscore)
- Non-invasive tear break-up time (NIBUT) and tear meniscus height measurements
- Slit-lamp biomicroscopy and corneal fluorescein staining
The study also examines how meibomian gland alterations correlate with systemic disease activity scores and inflammatory blood markers.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Syndromes, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis
- Keywords
- Ocular Surface Disease, Meibography, Meiboscore, Non-Invasive Tear Break-Up Time, Tear Meniscus Height, Ocular Surface Disease Index, Autoimmune Rheumatic Diseases, Corneal Fluorescein Staining
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes, Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Sjogren's Syndrome, Spondylitis, Ankylosing, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatologic Patients | Adult patients (aged 18 years or older) with an established diagnosis of one of five systemic autoimmune rheumatic diseases: Rheumatoid Arthritis (2010 ACR/EULAR criteria), Systemic Lupus Erythematosus (2019 EULAR/ACR criteria), Primary Sjogren's Syndrome (2016 ACR/EULAR criteria), Ankylosing Spondylitis (modified New York criteria), or Psoriatic Arthritis (CASPAR criteria) (n = 120). Participants undergo non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire. | |
| Healthy Controls | Age- and sex-matched healthy control subjects (aged 18 years or older) with no history of systemic autoimmune diseases and no active ocular surface complaints (n = 30). Participants undergo the same standardized ophthalmic assessment battery, including non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Gland Loss Assessed by Meiboscore
Meibomian gland drop-out is evaluated using non-contact infrared meibography and graded according to the Meiboscore scale for each eyelid (upper and lower): Grade 0 (no loss of meibomian glands), Grade 1 (gland loss involving less than one-third of the total area), Grade 2 (gland loss involving between one-third and two-thirds of the total area), and Grade 3 (gland loss involving more than two-thirds of the total area). Scores for the upper and lower eyelids are summed to yield a total Meiboscore per eye ranging from 0 to 6, where higher scores indicate greater meibomian gland loss and atrophy.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Saber Bakheet Gabra, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810569
- Sponsor's protocol ID
- MGD in Rheumatologic Patients
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients: A Cross-Sectional Analytical Study
- ClinicalTrials.gov ID
- NCT07810569
- Acronym / sponsor ID
- MGD in Rheumatologic Patients
- Conditions
- Meibomian Gland Dysfunction, Dry Eye Syndromes, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis
- Keywords
- Ocular Surface Disease, Meibography, Meiboscore, Non-Invasive Tear Break-Up Time, Tear Meniscus Height, Ocular Surface Disease Index, Autoimmune Rheumatic Diseases, Corneal Fluorescein Staining
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 9 Sep 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.
This observational study aims to assess the frequency and severity of Meibomian Gland Dysfunction (MGD) and associated ocular surface changes in patients with systemic autoimmune rheumatic diseases compared with healthy volunteers.
Meibomian glands are specialized glands in the eyelids that produce the lipid layer of tears, preventing tear evaporation. Systemic inflammation in rheumatologic conditions may affect these glands, leading to dry eye symptoms and ocular surface damage.
A total of 150 participants (120 rheumatologic patients and 30 healthy controls) will be evaluated in a single cross-sectional examination. Rheumatologic diagnoses include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, and Psoriatic Arthritis.
Participants will undergo a standardized series of non-invasive and minimally invasive eye examinations, including:
- An ocular symptom questionnaire (Ocular Surface Disease Index)
- Non-contact infrared meibography to assess meibomian gland loss (Meiboscore)
- Non-invasive tear break-up time (NIBUT) and tear meniscus height measurements
- Slit-lamp biomicroscopy and corneal fluorescein staining
The study also examines how meibomian gland alterations correlate with systemic disease activity scores and inflammatory blood markers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatologic Patients | – | –Adult patients (aged 18 years or older) with an established diagnosis of one of five systemic autoimmune rheumatic diseases: Rheumatoid Arthritis (2010 ACR/EULAR criteria), Systemic Lupus Erythematosus (2019 EULAR/ACR criteria), Primary Sjogren's Syndrome (2016 ACR/EULAR criteria), Ankylosing Spondylitis (modified New York criteria), or Psoriatic Arthritis (CASPAR criteria) (n = 120). Participants undergo non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire. |
| Healthy Controls | – | –Age- and sex-matched healthy control subjects (aged 18 years or older) with no history of systemic autoimmune diseases and no active ocular surface complaints (n = 30). Participants undergo the same standardized ophthalmic assessment battery, including non-invasive meibography, non-invasive tear break-up time (NIBUT), tear meniscus height (TMH), slit-lamp examination, corneal fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending outpatient rheumatology services at Assiut University and Al-Azhar University with confirmed diagnoses of systemic autoimmune rheumatic diseases (Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sjogren's Syndrome, Ankylosing Spondylitis, or Psoriatic Arthritis), alongside age- and sex-matched healthy control volunteers from the same geographic region with no systemic autoimmune disease or active ocular surface complaints.
Key inclusion criteria (9 listed)
- Age 18 years or older
- Ability to provide written informed consent
- For rheumatologic patients: Confirmed clinical diagnosis of one of the following autoimmune diseases:
- Rheumatoid Arthritis (2010 ACR/EULAR classification criteria)
- Systemic Lupus Erythematosus (2019 EULAR/ACR classification criteria)
Key exclusion criteria (7 listed)
- Chronic use of topical antiglaucoma eye drops
- Ocular surgery within the past 6 months
- Active ocular infection or active uveitis
- Contact lens wearers who have not discontinued wear for at least 2 weeks
- History of ocular chemical burns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Meibomian Gland Loss Assessed by Meiboscore
Time frame: Baseline
Meibomian gland drop-out is evaluated using non-contact infrared meibography and graded according to the Meiboscore scale for each eyelid (upper and lower): Grade 0 (no loss of meibomian glands), Grade 1 (gland loss involving less than one-third of the total area), Grade 2 (gland loss involving between one-third and two-thirds of the total area), and Grade 3 (gland loss involving more than two-thirds of the total area). Scores for the upper and lower eyelids are summed to yield a total Meiboscore per eye ranging from 0 to 6, where higher scores indicate greater meibomian gland loss and atrophy.
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 9 Sep 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction and Dry Eye Syndromes, 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 9 inclusion and 7 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 9 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibomian Gland Loss Assessed by Meiboscore (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.