Multi-model Image of Doxycycline in TAO
Primary Purpose
Thyroid Associated Ophthalmopathy
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Doxycycline Hyclate
Sponsored by
About this trial
This is an interventional screening trial for Thyroid Associated Ophthalmopathy focused on measuring Doxycycline, Thyroid Associated Ophthalmopathy, Extraorbital muscle, Orbit fat volume, Multi-modal image
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)
Sites / Locations
- Zhongshan Ophthalmic CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
doxycycline
Arm Description
patients administrated with doxycycline tablets 100mg orally per day
Outcomes
Primary Outcome Measures
change of extraocular muscle volume and orbital fat volume by MRI
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 Outcome Measures
change of exophthalmos
exophthalmos 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 Life
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.
change of eyelid aperture, lid retraction and lid lag
the values will be measured by the same investigator using the same millimeter ruler and the higher values change, the better the outcome is.
Full Information
NCT ID
NCT05112211
First Posted
October 27, 2021
Last Updated
April 16, 2023
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05112211
Brief Title
Multi-model Image of Doxycycline in TAO
Official Title
A Multi-model Image to Evaluate the Efficacy of Doxycycline in Thyroid Associated Ophthalmopathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Ophthalmopathy
Keywords
Doxycycline, Thyroid Associated Ophthalmopathy, Extraorbital muscle, Orbit fat volume, Multi-modal image
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients diagnosed by Thyroid-Associated Ophthalmopahty
Masking
None (Open Label)
Masking Description
Assessors who calculate the changes of the images are masked of the diagnosis and treatment.
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
doxycycline
Arm Type
Experimental
Arm Description
patients administrated with doxycycline tablets 100mg orally per day
Intervention Type
Drug
Intervention Name(s)
Doxycycline Hyclate
Intervention Description
patients administrated with doxycycline tablets 100mg orally per day
Primary Outcome Measure Information:
Title
change of extraocular muscle volume and orbital fat volume by MRI
Description
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.
Time Frame
at month 6
Secondary Outcome Measure Information:
Title
change of exophthalmos
Description
exophthalmos will be measured by the same investigator using the same Hertel instrument.
A higher change of exphthalmos means a better outcome.
Time Frame
at month 6
Title
change of Quality of Life
Description
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.
Time Frame
at month 6
Title
change of eyelid aperture, lid retraction and lid lag
Description
the values will be measured by the same investigator using the same millimeter ruler and the higher values change, the better the outcome is.
Time Frame
at month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Liang
Phone
(86)-87330402
Email
liangdan@gzzoc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuxi Chen
Phone
(86)-87330402
Email
chenyx293@mail2.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Liang
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Liang
Phone
(86)-87330402
Email
liangdan@gzzoc.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Multi-model Image of Doxycycline in TAO
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