Multi-model Image of Immunosuppressive Agents in TAO

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05110040
Collaborator
(none)
12
1
1
49.5
0.2

Study Details

Study Description

Brief Summary

This study aims to evaluate the efficacy of immunosuppressive agents treating Thyroid Associated Ophthalmopathy by multi-model image.

Condition or Disease Intervention/Treatment Phase
  • Drug: immunosuppressive agent
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
participants diagnosed of TAO administrated with immunosuppressive agentsparticipants 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.
Primary Purpose:
Treatment
Official Title:
A Multi-model Image of Immunosuppressive Agents in Thyroid Associated Ophthalmopathy.
Actual Study Start Date :
Oct 15, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: immunosuppressive agents

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

Drug: immunosuppressive agent
patients with TAO recruited in this study will administrated with immunosuppressive agent per day
Other Names:
  • immunosuppressive regulator
  • Outcome Measures

    Primary Outcome Measures

    1. change of macular sensibility [At 6 months]

      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

    1. change of extraocular muscle volume and orbital fat volume by MRI [at month 6]

      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.

    2. change of proptosis [at month 6]

      proptosis will be measured by the same investigator using the same Hertel instrument

    3. change of QoL [at month 6]

      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.

    4. change of eyelid aperture and lid lag [at month 6]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongshan Ophthalmic Center Guangzhou Guangdong China

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Dan Liang, Zhongshan Ophthalmic Center, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dan Liang, Dan Liang, PhD, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT05110040
    Other Study ID Numbers:
    • TAOIMTIMAGE
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dan Liang, Dan Liang, PhD, Sun Yat-sen University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021