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Multi-model Image of Doxycycline in TAO

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05112211
Enrollment
20
Registered
2021-11-08
Start date
2022-01-01
Completion date
2026-12-01
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Associated Ophthalmopathy

Keywords

Doxycycline, Thyroid Associated Ophthalmopathy, Extraorbital muscle, Orbit fat volume, Multi-modal image

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.

Interventions

patients administrated with doxycycline tablets 100mg orally per day

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Masking description

Assessors who calculate the changes of the images are masked of the diagnosis and treatment.

Intervention model description

Patients diagnosed by Thyroid-Associated Ophthalmopahty

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
change of extraocular muscle volume and orbital fat volume by MRIat month 63D 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

MeasureTime frameDescription
change of exophthalmosat month 6exophthalmos will be measured by the same investigator using the same Hertel instrument. A higher change of exphthalmos means a better outcome.
change of Quality of Lifeat month 6The 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.
change of eyelid aperture, lid retraction and lid lagat month 6the values will be measured by the same investigator using the same millimeter ruler and the higher values change, the better the outcome is.

Countries

China

Contacts

Primary ContactDan Liang
liangdan@gzzoc.com(86)-87330402
Backup ContactYuxi Chen
chenyx293@mail2.sysu.edu.cn(86)-87330402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026