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

Recruiting

• Conditions: Thyroid Eye Disease
• Interventions: Procedure: Modified multiple orbital wall decompression

• Registration Number: NCT05627401
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Study First Posted: 2022-11-25
• Last Update Posted: 2022-11-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Group Assignment	Modified multiple orbital wall decompression	patients with sight-threatening Graves orbitopathy (GO) who underwent customized/individual multiple orbital wall decompression plus fat removal

Primary Outcome Measures

Name	Time	Method
EVP	12 months	Visual Evoked Potential
proptosis	12 months	proptosis in mm
BCVA	12 months	best corrected visual acuity in logMAR
CAS	12 months	clinical activity score

Secondary Outcome Measures

Name	Time	Method
GO-QOL	12 months	Graves' Ophthalmopathy Quality of Life

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China