Dry eye syndrome caused by thyroid-associated ophthalmopathy
Conditions
Interventions
CsA Group:0.05% Cyclosporine
control group:Polyethylene glycol eye drops
Sponsors
Northern Theater Command General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets Bartley's diagnostic criteria for TAO: In addition to eyelid retraction, the patient must have one of the following indicators: thyroid dysfunction, proptosis, optic neuropathy, or extraocular muscle involvement; if eyelid retraction is absent, thyroid dysfunction must be present, along with one of the following indicators: proptosis, optic neuropathy, or extraocular muscle involvement, and other diseases causing similar signs must be excluded. (2) TAO patient's CAS score =18 years and =7 on the Chinese Dry Eye Questionnaire or an Ocular Surface Disease Index (OSDI) of >=13; and at the same time, the patient's fluorescein break-up time (FBUT) =7 on the Chinese Dry Eye Questionnaire or >=13 on the OSDI; and simultaneously, the patient's FBUT >5 s and =10 s or NIBUT 10~12 s, SIT (without anesthesia) >5 mm/5 min and =5 spots); (6) First-time discovery of dry eye symptoms and first-time administration of symptomatic treatment for dry eye. (7) The patient signs a written informed consent form, promising to cooperate with relevant ophthalmological examinations and undergo at least 3 months of follow-up.
Exclusion criteria
Exclusion criteria: (1) Individuals with pre-existing dry eye prior to the onset of thyroid-associated ophthalmopathy. (2) Patients with a history of eye surgery or trauma; those with acute ocular surface infection or inflammatory lesions; (3) Individuals with severe dysfunction of the liver, kidneys, cardiovascular system, or blood system; (4) Individuals with congenital antear syndrome, glaucoma, iritis, or other eye diseases; (5) Individuals with systemic diseases or other immune diseases besides thyroid dysfunction that can cause dry eye; (6) Pregnant or lactating women; (7) Individuals allergic to cyclosporine or other components of the drug; (8) Individuals allergic to polyethylene glycol or propylene glycol; (9) Individuals participating in other clinical trials during the follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non invasive tear film rupture time; | — |
Secondary
| Measure | Time frame |
|---|---|
| OSDI Questionnaire;Fluorescein tear film breakup time;Corneal fluorescein staining score;Envy rating and scoring;Non-invasive tear river height; | — |
Countries
China
Contacts
Public ContactChen Yingxin
Northern Theater Command General Hospital of the Chinese People's Liberation Army
Outcome results
None listed