Customized Multiple Orbital Wall Decompression for Sight-threatening Graves's Ophthalmopathy

Study Overview
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Brief Summary
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Graves' orbitopathy (GO) is an disfiguring and disabling autoimmune condition. Sight-threatening GO is an most severe form and occurs in about 5% of patients with Graves' disease. It can cause blurred vision, color vision and vision function damage, and affects the quality of life. The goal of this retrospective cohort study is to propose a customized orbital decompression algorithm for patients with sight-threatening Graves'ophthalmopathy and to explore the therapeutic effect of customized orbital decompression in sight-threatening patients.

Official Title
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Customized Modified Multiple Orbital Wall Decompression With Fat Removal for Sight-threatening Graves's Ophthalmopathy : a Retrospective Cohort Study

Conditions
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Thyroid Eye Disease

Intervention / Treatment
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* Procedure: Modified multiple orbital wall decompression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sight-threatening patients undergoing interdisciplinary discussion and orbital decompression operation. The sight-threatening GO refer to those with DON, exposure keratitis or corneal breakdown. DON was diagnosed according to the following clinical findings including optic nerve head edema, visual field defect, impaired color vision, afferent pupil defect, retinal folds, radiologic evidence of apical optic nerve compression or globe subluxation. Diagnosis of exposure keratitis or corneal breakdown was made based on physical exam signs, e.g. microepithelial defects, abrasion or ulcer. A minimum follow-up of 12 months was required for inclusion. Exclusion Criteria: Patients were excluded if exophthalmos, rather than acute visual loss, was the indication for surgery. Cases with a history of previous ocular surgery, glaucoma, and visual defects from other ocular conditions were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Group Assignment<br>patients with sight-threatening Graves orbitopathy (GO) who underwent customized/individual multiple orbital wall decompression plus fat removal | Procedure: Modified multiple orbital wall decompression<br>* Thyroid dysfunction of all patients is stabilized by ATDs until treatment of TAO is completed. All patients with sight-threatening GO were admitted for emergency steroid pulse therapy. And additional drugs for protecting gastrointestinal mucous membrane, potassium and calcium supplements, and sedatives were used. All emergency cases, whose signs of visual impairment clinically attributable to GO existed despite first-line steroid treatment, were referred and discussed at the surgical board of our interdisciplinary center for prompt surgical orbital decompression. Urgent orbital decompression was performed when response is absent or poor within 1-2 weeks.<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 | 12 months | 
| CAS | clinical activity score | 12 months | 
| proptosis | proptosis in mm | 12 months | 
| EVP | Visual Evoked Potential | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GO-QOL | Graves' Ophthalmopathy Quality of Life | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orbital decompression, Graves' orbitopathy, Dysthyroid optic neuropathy