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

Thyroid Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05627401
• Other study ID #: SYSKY-2022-349-01
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Peng Tian, PhD., M.D.
• Phone: +8615913171205
• Email: tianpeng3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Eye Disease

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	best corrected visual acuity in logMAR	12 months
Primary	CAS	clinical activity score	12 months
Primary	proptosis	proptosis in mm	12 months
Primary	EVP	Visual Evoked Potential	12 months
Secondary	GO-QOL	Graves' Ophthalmopathy Quality of Life	12 months