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Multi-model Image of Immunosuppressive Agents in TAO

Primary Purpose

Thyroid Associated Ophthalmopathy

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immunosuppressive agent
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Associated Ophthalmopathy focused on measuring Thyroid Associated Ophthalmopathy, Immunosuppressive agents, multi-modal image, function assessment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent
  • Age 18-70 years old
  • Diagnosed with TAO.

Exclusion Criteria:

  • Contraindications to immunosuppressive agents.
  • Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection.
  • Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents.
  • Patients 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

immunosuppressive agents

Arm Description

patients recruited will be treated with one or/and two immnuosuppressive agents

Outcomes

Primary Outcome Measures

change of macular sensibility
the same investigator uses the same instrument to assess the macular sensibility. The better change of macular sensibility means the better outcome.

Secondary Outcome Measures

change of extraocular muscle volume and orbital fat volume by MRI
A 3D MRI reconstructive model 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. The higher the value changes, the better the outcome is.
change of proptosis
proptosis will be measured by the same investigator using the same Hertel instrument
change of QoL
the score of quality of life will be assessed by the same investigator using GO-QoL. The higher change of quality of life means the better outcome.
change of eyelid aperture and lid lag
the values will be measured by the same investigator using the same millimeter ruler and the higher change of eyelid aperture and lid lag means the better outcome

Full Information

First Posted
October 27, 2021
Last Updated
April 16, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05110040
Brief Title
Multi-model Image of Immunosuppressive Agents in TAO
Official Title
A Multi-model Image of Immunosuppressive Agents in Thyroid Associated Ophthalmopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (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 immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model 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. 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. A great number of patients in inactive phase becoming refractory and reoccurring. Until now, the improvement of TAO is still be measured subjectively with low reliability and less accuracy. Multi-modal image is a new method to assess both the appearance and visual function of TAO and some of the indexes can be regarded as more apparent and stable in assessing the efficacy and prognosis of TAO. This perspective cohort study aims to evaluate the efficacy of immunosuppressive agents in TAO by multi-model image and function assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Associated Ophthalmopathy
Keywords
Thyroid Associated Ophthalmopathy, Immunosuppressive agents, multi-modal image, function assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
participants diagnosed of TAO administrated with immunosuppressive agents
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
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
immunosuppressive agents
Arm Type
Experimental
Arm Description
patients recruited will be treated with one or/and two immnuosuppressive agents
Intervention Type
Drug
Intervention Name(s)
immunosuppressive agent
Other Intervention Name(s)
immunosuppressive regulator
Intervention Description
patients with TAO recruited in this study will administrated with immunosuppressive agent per day
Primary Outcome Measure Information:
Title
change of macular sensibility
Description
the same investigator uses the same instrument to assess the macular sensibility. The better change of macular sensibility means the better outcome.
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
change of extraocular muscle volume and orbital fat volume by MRI
Description
A 3D MRI reconstructive model 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. The higher the value changes, the better the outcome is.
Time Frame
at month 6
Title
change of proptosis
Description
proptosis will be measured by the same investigator using the same Hertel instrument
Time Frame
at month 6
Title
change of QoL
Description
the score of quality of life will be assessed by the same investigator using GO-QoL. The higher change of quality of life means the better outcome.
Time Frame
at month 6
Title
change of eyelid aperture and lid lag
Description
the values will be measured by the same investigator using the same millimeter ruler and the higher change of eyelid aperture and lid lag means the better outcome
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: Contraindications to immunosuppressive agents. Patients with HIV, Hepatitis B or C, Tuberculosis or other active significant infection. Patients with severe chronic diseases in heart, lung, kidney and liver, which make it not tolerant to immunosuppressive agents. Patients 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 Immunosuppressive Agents in TAO

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