Multi-model Image of Immunosuppressive Agents in TAO

Not Applicable

Recruiting

• Conditions: Thyroid Associated Ophthalmopathy
• Interventions: Drug: immunosuppressive agent

• Registration Number: NCT05110040
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-10-27
• Study First Posted: 2021-11-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immunosuppressive agents	immunosuppressive agent	patients recruited will be treated with one or／and two immnuosuppressive agents

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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
change of proptosis	at month 6	proptosis will be measured by the same investigator using the same Hertel instrument

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China