Skip to content

The ocular surface function and microenvironment changes in patients with autoimmune disease related dry eye

The ocular surface function and microenvironment changes in patients with autoimmune disease related dry eye: a prospective and observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090804
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-21

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

Conditions

Autoimmune disease related dry eye

Interventions

SS group:none
SSc group:none

Sponsors

Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 70, regardless of gender. (2) Participants suffer from autoimmune diseases that meet the ACR/EULAR diagnostic criteria, including rheumatoid arthritis, systemic lupus erythematosus, Sjögren's syndrome, ankylosing spondylitis, and systemic sclerosis. (3) Patients diagnosed with dry eye disease according to the "Chinese Expert Consensus on Dry Eye (2020)". (4) Participants will undergo screening diagnosis and follow-up activities at our center. (5) BCVA = 0.6. (6) The average of three IOP measurements during screening = 21 mmHg. (7) Participants willing to discontinue wearing contact lenses during the study period. (8) Subjective cooperation and participants are able to sign a written informed consent form. A signed, dated informed consent form is required, indicating that the patient (or a legal representative) has been informed of all relevant information about the study.

Exclusion criteria

Exclusion criteria: Subjects who met any of the following criteria were not eligible for inclusion in the study: (1) Previous history of diabetes, hyperlipidemia, AIDS, sarcoidosis et al. (2) Patients with previous hematopoietic stem cell transplantation (3) Unable to complete the ocular surface disease index (OSDI) questionnaire (4) History of ocular surgery within 6 months before screening (5) Ocular surface dystrophy or infection, systemic treatment with drugs with corneal toxicity (6) History of cataract, glaucoma and other eye diseases affecting vision (7) Except from anti-infective drugs, systemic or topical immunosuppressive agents/corticosteroids, using of other drugs that may affect the ocular surface during treatment, such as oral analgesics, antidepressants, antipsychotic drugs, anti-Parkinson drugs, antihistamines, estrogen derivatives, and topical anti-glaucoma eye drops.

Design outcomes

Primary

MeasureTime frame
Ocular Surface Disease Index;Tear film quality and ocular surface conditions;Tear fluid inflammatory cytokines;

Secondary

MeasureTime frame
Conjunctival biomarkers;Ocular surface microorganism;

Countries

China

Contacts

Public ContactBilian Ke

Department of Ophthalmology, Renji Hospital, Shanghai Jiao Tong University School of Medicine

kebilian@126.com+86 133 8625 9873

Outcome results

None listed

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