Multi-model Image of Doxycycline in TAO
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 →
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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