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Recruiting NCT06588764

Modified Orbital Decompression in the Treatment of Moderate-to-severe Grave's Ophthalmopathy

No phase Interventional Graves Ophthalmopathy Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: modified deep lateral and/or medial wall decompression.
Who it may be relevant to
Registry conditions: Graves Ophthalmopathy, Surgery. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study

Overview

To investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for Moderate-to-severe Grave's Ophthalmopathy.

Detailed description

The purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of Moderate-to-severe Grave's Ophthalmopathy.

Interventions

  • Procedure modified deep lateral and/or medial wall decompression
    Modified deep lateral orbital wall decompression is based on traditional outer wall decompression with combined abrasion of the deep outer orbital wall (including the greater pterygoid wing) to achieve adequate enlargement of the orbital cavity.

Primary outcome measures

  • best corrected visual acuity (BCVA) [Time frame: within 24 weeks of surgery]
Secondary outcome measures (7)
  • value of Hertel [Time frame: within 24 weeks of surgery]
  • the mean deviation value of visual field (VF) [Time frame: 24 weeks after surgery]
  • pattern standard deviation value of visual field [Time frame: within 24 weeks of surgery]
  • the P100 latency of pattern visual evoked potential (PVEP) [Time frame: within 24 weeks of surgery]
  • N75-p100 amplitude of PVEP [Time frame: within 24 weeks of surgery]
  • clinical activity score (CAS) [Time frame: within 24 weeks of surgery]
  • volume of adipose tissue [Time frame: during the surgery]

Eligibility criteria

Inclusion criteria

  • EUGOGO/NOSPECS grade was moderate-to-severe thyroid associate ophthalmopathy;
  • CAS≤3 score;
  • stable thyroid function for at least 6 months;
  • able and willing to participate in clinical trials and ensure regular follow-up;

Exclusion criteria

  • any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors);
  • B-ultrasound or CT, MRI found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.);
  • uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases
  • those who were considered by the researchers to be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT06588764 · yanghs20240821

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗