Customized Multiple Orbital Wall Decompression for Sight-threatening Graves's Ophthalmopathy
NCT ID: NCT05627401
Last Updated: 2022-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
78 participants
OBSERVATIONAL
2021-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Single Group Assignment
patients with sight-threatening Graves orbitopathy (GO) who underwent customized/individual multiple orbital wall decompression plus fat removal
Modified multiple orbital wall decompression
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.
Interventions
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Modified multiple orbital wall decompression
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cases with a history of previous ocular surgery, glaucoma, and visual defects from other ocular conditions were excluded from the study.
18 Years
65 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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Peng Tian, PhD., M.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Tian P, Zeng P, Zhang H, Liang J, Li E, Ma Y, Zou H, Wang M, Xiang L. Balanced medial-lateral wall vs selective 3-wall orbital decompression for sight-threatening Graves's orbitopathy: a clinical retrospective cohort study from 2016 to 2022. Eur Arch Otorhinolaryngol. 2024 Sep;281(9):4807-4815. doi: 10.1007/s00405-024-08589-x. Epub 2024 Apr 13.
Other Identifiers
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SYSKY-2022-349-01
Identifier Type: -
Identifier Source: org_study_id
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