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NCT04096612 Clinical Trial

The Therapeutic Effect of Dysthyroid Optic Neuropathy

Thyroid Eye Disease Clinical Trial

Official title:
The Therapeutic Effect of Dysthyroid Optic Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04096612
Other study ID # yanghs2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date December 31, 2019

Study information
Verified date September 2019
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Thyroid associated ophthalmopathy (TAO) is a common autoimmune disorder. The pathogenesis of TAO is unclear, and studies found that T cell, B cell and monocytes, macrophages and mast cells are located in the orbital tissue of TAO. Dysthyroid optic neuropathy (DON) is the most serious complication of TAO, which can cause blurred vision, color vision and vision function damage, and affects the quality of life. Investigation of the therapeutic effect of orbital decompression may provide some clues to make the policy at treatment of DON. We explore the therapeutic effect of orbital decompression in patients with DON in both eyes.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Ability to perform visual fields and VEP examination Without any serious systemic diseases Without any surgery on eyes in six months

Exclusion Criteria:

- With any serious systemic diseases With any surgery on eyes in six months

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Orbital decompression combined with MPT
Orbital decompression combined with MPT

Locations
Country Name City State
China Zhongshan Opthalmic Center Guangdong Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary BCVA best corrected visual acuity in logMAR 6 months
Primary IOP intraocular pressure in mmHg 6 months
Primary proptosis proptosis in mm 6 months
Primary upper eyelid retraction upper eyelid retraction in mm 6 months
Primary CAS clinical activity score 6 months
Secondary MD mean deviation of visual field in dB 6 months
Secondary PSD pattern standard deviation of visual field in dB 6 months
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