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Study on the relationship between air pollution and tear film stability in dry eye patients

Study on the relationship between air pollution and tear film stability in dry eye patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061056
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry eye

Interventions

normal control group:Examination of dry eye related indicators
Sjogren's syndrome group:Examination of dry eye related indicators
Meibomian gland dysfunction group:Examination of dry eye related indicators

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with Sjogren's syndrome: SICCA classification criteria are selected to diagnose Sjogren's syndrome (SS). The diagnosis of SS requires at least 2 of the following 3 criteria: seropositivity (anti-SSA and/or anti-SSB or rheumatoid factor-positive, anti-nuclear Antibody >= 1:320); ocular staining score >= 3 (9-13); focal lymphocytic sialadenitis with a lesion score >= 1 lesion/4mm2 in labial gland biopsy; 2. Meibomian gland dysfunction (MGD) patients: The diagnosis of MGD is mainly based on physical signs, reference symptoms and corresponding auxiliary examination results, and a comprehensive evaluation is carried out.(1) Abnormal opening of eyelid margin and meibomian glands; (2) Abnormal secretion of meibomian; (3) Ocular symptoms; (4) Absence of meibomian glands; (5) Abnormal thickness of lipid layer. Any one of items 1 and 2 can be diagnosed with abnormal meibomian glands. Combined with the ocular symptoms of item 3, those with symptoms are diagnosed with MGD, and those with asymptomatic symptoms are diagnosed with abnormal meibomian gland function. These patients will eventually develop for MGD. Items 4 and 5 are enhanced diagnostic indicators. Items 4 or 5 appear alone, only indicating the absence of meibomian glands and changes in lipid layer thickness and their extent, and the diagnosis should be made in combination with other test results; 3. Aged >= 18 years; 4. BCVA >= 20/40; 5. The SS group required SICCA to diagnose SS, the MGD group met the MGD diagnosis, and the control group had no evidence of ocular surface disease; 6. Residing in the study area for at least 5 years.

Exclusion criteria

Exclusion criteria: 1. Smoking, heavy drinking; 2. It is possible to travel to other areas during the monitoring period; 3. Contact with chemical solutions such as organic solvents, sodium hypochlorite and formalin; 4. Wear contact lenses; 5. The video terminal is used for more than 6 hours per day; 6. Eye surgery or pre-existing eye diseases, such as blepharitis, allergic conjunctivitis, non-SS dry eye, uveitis, high myopia, eyelid insufficiency, etc.; 7. Hypertension, diabetes, hyperthyroidism, rheumatoid arthritis and other systemic diseases and autoimmune diseases that may affect tear secretion; 8. Nutrient-related diseases such as essential fatty acid deficiency or vitamin deficiency; 9. Taking antihistamines, antidepressants, isotretinoin, anticholinergic drugs, beta blockers, diuretics and other drugs that may affect tear secretion; 10. Failure to comply with the research protocol.

Design outcomes

Primary

MeasureTime frame
Tear film lipid layer thickness;

Secondary

MeasureTime frame
Ocular Surface Disease Index Score;tear film breakup time;Eye redness index;Schirmer's test;Schirmer's test;corneal fluorescein staining;Meibomian gland infrared photography;Imprinting cytology;Tear inflammatory factor detection;Schirmer's test;

Countries

China

Contacts

Public ContactWang He

The Affiliated Hospital of Xuzhou Medical University

wanghe1111@163.com+86 15262011860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026