Multi-model Image of Doxycycline in TAO

Thyroid Associated Ophthalmopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05112211
• Other study ID #: TAODOXYIMAGE
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: Dan Liang
• Phone: (86)-87330402
• Email: liangdan[@]gzzoc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Associated Ophthalmopathy
• Thyroid Diseases

Intervention

Drug:
• Doxycycline Hyclate
patients administrated with doxycycline tablets 100mg orally per day

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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