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

NCT ID: NCT06588764

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2026-01-31

Brief Summary

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.

Conditions

Graves Ophthalmopathy; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

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

Group Type: EXPERIMENTAL

modified deep lateral and/or medial wall decompression

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Huasheng Yang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hua sheng Yang, M.D,PHD

Role: CONTACT

yanghs64@162.com

+8620-87331539

Facility Contacts

Huasheng Yang, M.D, PHD

Role: primary

yanghs64@126.com

+8613602721743

Other Identifiers

yanghs20240821

Identifier Type: -

Identifier Source: org_study_id