Thyroid Associated Ophthalmopathy
Conditions
Keywords
Thyroid Associated Ophthalmopathy, Immunosuppressive agents, multi-modal image, function assessment
Brief summary
This study aims to evaluate the efficacy of immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model image.
Detailed description
Thyroid Associated Ophthalmopathy is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. TAO can be classified into active phase and inactive phase according to the activity score and wait-and-see or surgery are widely chosen for patients in inactive phase. A great number of patients in inactive phase becoming refractory and reoccurring. Until now, the improvement of TAO is still be measured subjectively with low reliability and less accuracy. Multi-modal image is a new method to assess both the appearance and visual function of TAO and some of the indexes can be regarded as more apparent and stable in assessing the efficacy and prognosis of TAO. This perspective cohort study aims to evaluate the efficacy of immunosuppressive agents in TAO by multi-model image and function assessments.
Interventions
patients with TAO recruited in this study will administrated with immunosuppressive agent per day
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Assessors who calculate the changes of the images are masked of the diagnosis and treatment.
Intervention model description
participants diagnosed of TAO administrated with immunosuppressive agents
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age 18-70 years old * Diagnosed with TAO.
Exclusion criteria
* Contraindications to immunosuppressive agents. * Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection. * Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents. * Patients have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of macular sensibility | At 6 months | the same investigator uses the same instrument to assess the macular sensibility. The better change of macular sensibility means the better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of extraocular muscle volume and orbital fat volume by MRI | at month 6 | A 3D MRI reconstructive model will be established and the volume of extraocular muscle and orbital fat will be calculated by the same advanced programmer who is blinded of the pre- or post- treatment images order. The higher the value changes, the better the outcome is. |
| change of proptosis | at month 6 | proptosis will be measured by the same investigator using the same Hertel instrument |
| change of QoL | at month 6 | the score of quality of life will be assessed by the same investigator using GO-QoL. The higher change of quality of life means the better outcome. |
| change of eyelid aperture and lid lag | at month 6 | the values will be measured by the same investigator using the same millimeter ruler and the higher change of eyelid aperture and lid lag means the better outcome |
Countries
China
Contacts
Primary ContactDan Liang
Backup ContactYuxi Chen
Outcome results
None listed