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NCT Number: NCT05112211

Multi-model Image of Doxycycline in TAO

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

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Key information

Conditions

Thyroid Associated Ophthalmopathy Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Dan Liang

CONTACT

[email protected]

（86）-87330402

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Doxycycline Hyclate

Drug

patients administrated with doxycycline tablets 100mg orally per day

Primary outcomes

  1. change of extraocular muscle volume and orbital fat volume by MRI

    Time frame: 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 outcomes

  1. change of exophthalmos

    Time frame: 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.

  2. change of Quality of Life

    Time frame: 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.

  3. change of eyelid aperture, lid retraction and lid lag

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Liang

CONTACT

[email protected]

（86）-87330402

Yuxi Chen

CONTACT

[email protected]

（86）-87330402

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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