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Multi-model Image of Doxycycline in TAO

NCT ID: NCT05112211

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2026-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Thyroid Associated Ophthalmopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients diagnosed by Thyroid-Associated Ophthalmopahty
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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

Study Groups

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doxycycline

patients administrated with doxycycline tablets 100mg orally per day

Group Type EXPERIMENTAL

Doxycycline Hyclate

Intervention Type DRUG

patients administrated with doxycycline tablets 100mg orally per day

Interventions

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Doxycycline Hyclate

patients administrated with doxycycline tablets 100mg orally per day

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Dan Liang

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan Liang

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dan Liang

Role: CONTACT

[email protected]
（86）-87330402

Yuxi Chen

Role: CONTACT

[email protected]
（86）-87330402

Facility Contacts

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Dan Liang

Role: primary

[email protected]
（86）-87330402

Other Identifiers

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TAODOXYIMAGE

Identifier Type: -

Identifier Source: org_study_id