Clinical trial NCT03107078: Using A Novel Classification System in Intravenous GCs Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
Official title: Using A Novel Classification System in Intravenous Glucocorticoids Therapy of TAO: A Multi-central, Randomized, Open, Superior Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thyroid Associated Ophthalmopathy
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The Fifth Affiliated Hospital of Southern Medical University
name: Huadu District People's Hospital of Guangzhou
name: Zhujiang Hospital
First posted: 2017-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For patients with active moderate-to-severe thyroid associated ophthalmopathy (TAO), the Intravenous Glucocorticoids (GCs) is the recommended therapy. However, the efficacy of GCs is not satisfied. Investigators established a novel classification of TAO for the first time to assess more precisely for better personal treatment.

Detailed description: TAO is one of most common extra thyroid manifestation of dysfunctional thyroid disease. Since the morbidity of TAO has been increasing rapidly, Investigators' team is intended to verify the feasibility of the new type of classification system established by the related parameters of orbital MRI scan. Based on classification, investigators compare the efficacy of two GCs therapy. According to MRI,investigators measure the optimal T2 signal intensity ratio (SIR) for the treatment of TAO, which may help to find a better treatment time for therapy.

Eligibility criteria: Inclusion Criteria:

1. The diagnostic standard of TAO is according to Bartley's criteria.
2. Patients with active moderate-to-severe TAO based on 2016 EUGOGO guidelines.
3. CAS≥3/7.
4. None of the patients received any glucocorticoids therapy or orbital radiotherapy in the previous 3 months.

Exclusion Criteria:

1. NOSPECS is 0 or 1.Only signs,no symptoms.Signs include:reduced blink(Stellwag symptoms),two reduced cohesion(Mobius levy),moving slowly on the eyelids(Von Graefe sign),to the point of view,the forehead wrinkled skin should not(Joffroyv levy).
2. Suffering from other eye diseases or wearing contact lenses.
3. Suffering from other autoimmune diseases.
4. Acute and chronic infectious diseases.
5. Diabetic retinopathy or hypertensive fundus lesions.
6. Patients received orbital decompression or other orbital surgery.
7. Suffering from eye trauma or ocular surface disease.
8. Special occupants, and the working environment has obvious air pollution etc.

Primary outcomes:
measure: Number of patients defined as Response for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
timeFrame: 2years
measure: Number of patients defined as Deterioration for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
timeFrame: 2years
measure: Number of patients defined as Unchange for the Glucocorticoids Treatment based on the 7 parameters of eye assessment
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Third Affiliated Hospital of Southern Medical University
state: Guangdong
Study officials:
References: