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

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.

Study Overview

• Status: Recruiting
• Conditions: Thyroid Eye Disease
• Intervention / Treatment: Procedure: Modified multiple orbital wall decompression

• Study Type: Observational
• Enrollment (Anticipated): 78

Contacts and Locations

• Study Contact: Name: Peng Tian, PhD., M.D.; Phone Number: +8615913171205; Email: tianpeng3@mail.sysu.edu.cn
• Study Contact Backup: Name: Mei Wang, PhD., M.D.; Phone Number: +8613724856155; Email: wangmei2@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Peng Tian, PhD., M.D.; Phone Number: +86 81332449; Email: tianpeng3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This was a retrospective cohort study of patients with sight-threatening Graves orbitopathy (GO) who underwent customized/individual multiple orbital wall decompression plus fat removal at Sun Yat-Sen Memorial Hospital from Jan. 2017 to Dec. 2021.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Investigators: Principal Investigator: Peng Tian, PhD., M.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 25, 2022

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Graves' orbitopathy; Orbital decompression; Dysthyroid optic neuropathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Thyroid Diseases; Eye Diseases, Hereditary; Graves Disease; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Eye Diseases; Graves Ophthalmopathy
• Other Study ID Numbers: SYSKY-2022-349-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Medical records or outpatient examination records cannot be shared by hospitals across the country.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No