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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05627401
Collaborator
(none)
78
1
24
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Modified multiple orbital wall decompression

Study Design

Study Type:
Observational
Anticipated Enrollment :
78 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Customized Modified Multiple Orbital Wall Decompression With Fat Removal for Sight-threatening Graves's Ophthalmopathy : a Retrospective Cohort Study
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. BCVA [12 months]

    best corrected visual acuity in logMAR

  2. CAS [12 months]

    clinical activity score

  3. proptosis [12 months]

    proptosis in mm

  4. EVP [12 months]

    Visual Evoked Potential

Secondary Outcome Measures

  1. GO-QOL [12 months]

    Graves' Ophthalmopathy Quality of Life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sun Yat-sen Memorial Hospital Guangzhou Guangdong China 510120

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Peng Tian, PhD., M.D., Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT05627401
Other Study ID Numbers:
  • SYSKY-2022-349-01
First Posted:
Nov 25, 2022
Last Update Posted:
Nov 25, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 25, 2022