Multi-model Image of Doxycycline in TAO

Study Overview
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Brief Summary
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This study aims to evaluate the efficacy of doxycycline treating Thyroid Associated Ophthalmopathy by multi-modal image.

Detailed Description
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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. Different degrees of exophthalmos, eyelid aperture, lid retraction and lid lag are common symptoms apprearing in TAO. The improvement of exophthalmos is usually measured with Hertel instrument and the change of eyelid is measured with millimeter ruler. All these measurements are subjective, low reliable and less accurate. 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. But still a progression and reoccurrence can be a big challenge for ophthalmologists. This is a perspective cohort study to evaluate the efficacy of doxycycline in TAO by multi-model image.

Official Title
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A Multi-model Image to Evaluate the Efficacy of Doxycycline in Thyroid Associated Ophthalmopathy

Conditions
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Thyroid Associated Ophthalmopathy

Intervention / Treatment
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* Drug: Doxycycline Hyclate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent Age 18-70 years old Diagnosed with TAO Exclusion Criteria: Sight-threatening TAO with dysthyroid optic neuropathy Allergy of tetracycline Have contraindications of MRI(metal pacemaker, fake teeth, foreign body and other materials which will disturb the examination)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Patients diagnosed by Thyroid-Associated Ophthalmopahty
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: doxycycline<br>patients administrated with doxycycline tablets 100mg orally per day | Drug: Doxycycline Hyclate<br>* patients administrated with doxycycline tablets 100mg orally per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of extraocular muscle volume and orbital fat volume by MRI | 3D MRI image 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. A higher score means a better outcome. | at month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of exophthalmos | exophthalmos will be measured by the same investigator using the same Hertel instrument. A higher change of exphthalmos means a better outcome. | at month 6 | 
| change of Quality of Life | The score of quality of life will be assessed by the same investigator using GO-QoL. The better change of quality of life means a better outcome. | at month 6 | 
| change of eyelid aperture, lid retraction and lid lag | the values will be measured by the same investigator using the same millimeter ruler and the higher values change, the better the outcome is. | at month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extraorbital muscle, Orbit fat volume, Multi-modal image, Doxycycline, Thyroid Associated Ophthalmopathy