The Therapeutic Effect of Dysthyroid Optic Neuropathy

Study Overview
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Brief Summary
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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.

Official Title
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The Therapeutic Effect of Dysthyroid Optic Neuropathy

Conditions
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Thyroid Eye Disease

Intervention / Treatment
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* Procedure: Orbital decompression combined with MPT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orbital decompression combined MPT<br>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. | Procedure: Orbital decompression combined with MPT<br>* Orbital decompression combined with MPT<br>|
| Experimental: Separate MPT<br>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. | Procedure: Orbital decompression combined with MPT<br>* Orbital decompression combined with MPT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | best corrected visual acuity in logMAR | 6 months | 
| IOP | intraocular pressure in mmHg | 6 months | 
| proptosis | proptosis in mm | 6 months | 
| upper eyelid retraction | upper eyelid retraction in mm | 6 months | 
| CAS | clinical activity score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MD | mean deviation of visual field in dB | 6 months | 
| PSD | pattern standard deviation of visual field in dB | 6 months |