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

NCT05627401 | Unknown DMC

• 1 other identifier: SYSKY-2022-349-01
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Eye Disease

Keywords

Orbital decompression; Graves' orbitopathy; Dysthyroid optic neuropathy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• GO-QOL

  12 months

Study Arms (1)

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

Interventions

Modified multiple orbital wall decompression PROCEDURE

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.

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38613579 DERIVED

MeSH Terms

Conditions

Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peng Tian, PhD., M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Tian, PhD., M.D.

CONTACT

+8615913171205; tianpeng3@mail.sysu.edu.cn

Mei Wang, PhD., M.D.

CONTACT

+8613724856155; wangmei2@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 25, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 25, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)