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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05627401
Enrollment
78
Registered
2022-11-25
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2022-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease

Keywords

Orbital decompression, Graves' orbitopathy, Dysthyroid optic neuropathy

Brief summary

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.

Interventions

PROCEDUREModified 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.

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
BCVA12 monthsbest corrected visual acuity in logMAR
CAS12 monthsclinical activity score
proptosis12 monthsproptosis in mm
EVP12 monthsVisual Evoked Potential

Secondary

MeasureTime frameDescription
GO-QOL12 monthsGraves' Ophthalmopathy Quality of Life

Countries

China

Contacts

Primary ContactPeng Tian, PhD., M.D.
tianpeng3@mail.sysu.edu.cn+8615913171205
Backup ContactMei Wang, PhD., M.D.
wangmei2@mail.sysu.edu.cn+8613724856155

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026