Study of Therapeutic Value of Periorbital Injection of Glucocorticoid in Mild TAO

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Thyroid Associated Ophthalmopathy

Treatments: Drug: Glucocorticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT04548284

yanghs202009

Details and patient eligibility

About

The purpose of this study is to determine whether periorbital injection of glucocorticoid is effective and necessary in the treatment of mild TAO.

Enrollment: 142 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

General conditions:

1. clinically diagnosed as thyroid disease;
2. able and willing to participate in clinical trials and ensure regular follow-up.

Eye condition:

1. patients with monocular disease diagnosed by TAO;
2. EUGOGO/NOSPECS grade was mild and CAS score was less than 3;
3. the course of eye disease was less than 12mo and had not been treated in the past.

Exclusion criteria

General situation:

1. patients with poor blood glucose control in recent 3 months, glycosylation ≥ 10% ;
2. blood pressure still fluctuated > 180/110mmHg after medication;
3. obvious liver and kidney insufficiency;
4. contraindications for the use of glucocorticoids (peptic ulcer, osteoporosis, severe infection, psychosis, etc.);
5. patients with severe abnormal blood coagulation;
6. patients with other systemic immune diseases;
7. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
8. history of chronic infection;
9. pregnant and lactating women.

Eye conditions:

1. B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
2. moderate to severe TAO, in either eye requiring local or systemic treatment;
3. periorbital infectious diseases, hemorrhagic diseases;
4. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases.
5. those who studied the eyes who had a history of arbitrary surgery;
6. those who were considered by the researchers to be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

Periorbitally Injected Glucocorticoids

Experimental group

Description:

Glucocorticoids periorbital injection. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.

Treatment:

Drug: Glucocorticoids

Observe

No Intervention group

Description:

Observe and wait.