Multi-model Image of Doxycycline in TAO

Not Applicable

Recruiting

• Conditions: Thyroid Associated Ophthalmopathy
• Interventions: Drug: Doxycycline Hyclate

• Registration Number: NCT05112211
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-05
• Study First Posted: 2021-11-08
• Study Start: 2022-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
doxycycline	Doxycycline Hyclate	patients administrated with doxycycline tablets 100mg orally per day

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China