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Recruiting NCT05112211

Multi-model Image of Doxycycline in TAO

No phase Interventional Thyroid Associated Ophthalmopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Doxycycline Hyclate.
Who it may be relevant to
Registry conditions: Thyroid Associated Ophthalmopathy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • change of extraocular muscle volume and orbital fat volume by MRI [Time frame: at month 6]
Secondary outcome measures (3)
  • change of exophthalmos [Time frame: at month 6]
  • change of Quality of Life [Time frame: at month 6]
  • change of eyelid aperture, lid retraction and lid lag [Time frame: at month 6]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center — Guangzhou

Identifiers

NCT: NCT05112211 · TAODOXYIMAGE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗