The Therapeutic Effect of Dysthyroid Optic Neuropathy

Sun Yat-sen University

Status: Unknown

Conditions: Thyroid Eye Disease

Treatments: Procedure: Orbital decompression combined with MPT

Study type: Interventional

Funder types: Other

Identifiers

NCT04096612

yanghs2018

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Orbital decompression combined MPT

Experimental group

Description:

Orbital decompression was performed by the same doctor with rich clinical experience. MPT should be implemented in the patients with obvious thyroid disorder before orbital decompression surgery which should only be performed when thyroid function was stabilized. The surgery was performed under general anesthesia. An arcuate incision was made in the skin 2 mm below the lower eyelid margin, and the tissue under the incision were separated to the periorbita and orbital septum. Part of the medial orbital wall, inferior orbital wall and partial tissue of ethmoidal sinus were removed, and an appropriate amount of adipose tissue was excised. MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.

Treatment:

Procedure: Orbital decompression combined with MPT

Separate MPT

Experimental group

Description:

MPT was conducted after the surgery, at a dose of 1g methylprednisolone per day through intravenous injection for 3 consecutive days with a total amount of 3g methylprednisolone. After 3 days of intravenous injection of methylprednisolone, prednisone was orally taken by the patients at a dose of 30 mg/day which was gradually reduced.

Treatment:

Procedure: Orbital decompression combined with MPT