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

Sun Yat-sen University

Status: Enrolling

Conditions: Graves Ophthalmopathy; Surgery

Treatments: Procedure: modified deep lateral and/or medial wall decompression

Study type: Interventional

Funder types: Other

Identifiers

NCT06588764

yanghs20240821

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Study group

Experimental group

Description:

Modified deep lateral and/or medial wall decompression in Moderate-to-severe Graves' Orbitopathy

Treatment:

Procedure: modified deep lateral and/or medial wall decompression