Multi-model Image of Doxycycline in TAO

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05112211

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Thyroid Associated Ophthalmopathy	Drug: Doxycycline Hyclate	N/A

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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients diagnosed by Thyroid-Associated OphthalmopahtyPatients diagnosed by Thyroid-Associated Ophthalmopahty

Masking:

None (Open Label)

Masking Description:

Assessors who calculate the changes of the images are masked of the diagnosis and treatment.

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: doxycycline patients administrated with doxycycline tablets 100mg orally per day	Drug: Doxycycline Hyclate patients administrated with doxycycline tablets 100mg orally per day

Arm

Intervention/Treatment

Experimental: doxycycline

patients administrated with doxycycline tablets 100mg orally per day

Drug: Doxycycline Hyclate

patients administrated with doxycycline tablets 100mg orally per day

Outcome Measures

Primary Outcome Measures

change of extraocular muscle volume and orbital fat volume by MRI [at month 6]
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.

Secondary Outcome Measures

change of exophthalmos [at month 6]
exophthalmos will be measured by the same investigator using the same Hertel instrument. A higher change of exphthalmos means a better outcome.
change of Quality of Life [at month 6]
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.
change of eyelid aperture, lid retraction and lid lag [at month 6]
the values will be measured by the same investigator using the same millimeter ruler and the higher values change, the better the outcome is.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)