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

NCT ID: NCT05627401

Last Updated: 2022-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Thyroid Eye Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single Group Assignment

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

Modified multiple orbital wall decompression

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peng Tian, PhD., M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Tian, PhD., M.D.

Role: CONTACT

+8615913171205

Mei Wang, PhD., M.D.

Role: CONTACT

+8613724856155

Facility Contacts

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Peng Tian, PhD., M.D.

Role: primary

+86 81332449

References

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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.

Reference Type DERIVED
PMID: 38613579 (View on PubMed)

Other Identifiers

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SYSKY-2022-349-01

Identifier Type: -

Identifier Source: org_study_id

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