Thyroid eye disease
Conditions
Interventions
Lutein Group:Participants in lutein group will take 10mg of lutein orally once a day
Control group:Participants in control group will take 10mg of placebo orally once a day
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of mild thyroid eye disease (TED) meeting established clinical criteria ; 2. Over 18 years old but under 70 years old, with an eye disease duration of =2 months post-antithyroid drugs or thyroid surgery; 4. No planned use of systemic glucocorticoids, orbital radiotherapy, or TED-specific therapies during the study unless disease progression occurs; 5. Presence of >=1 objective TED sign (e.g., lid retraction, proptosis, ocular motility restriction); 6. No prior TED treatment except for local therapies (e.g., lubricating eye drops).
Exclusion criteria
Exclusion criteria: 1. Moderate-to-severe TED; 2. Proptosis >22 mm; 3. Diplopia in primary gaze or reading position and/or strabismus; 4. Signs or manifestations of optic nerve involvement; 5. Pregnancy; 6. Drug abuse or severe alcoholism; 7. Severe systemic diseases; 8. Inability to comply with the study protocol; 9. Known hypersensitivity to the investigational drug(s); 10. Decompensated liver cirrhosis or acute liver failure;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree of extraocular muscle involvement;Eyelid retraction;Proptosis;The score of GO-QOL subscales ;NO SPECS classification; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Vision;Intraocular pressure;Thyroid function;Serum lipid level;Thyroid-associated antibody; | — |
Countries
China
Contacts
Public ContactWei Xiong
The Third Xiangya Hospital of Central South University
Outcome results
None listed