Surgery for moderate-to-severe Graves' eye disease
Modified Deep Lateral Wall Decompression and/or Deep Medial Wall Decompression for Moderate-to-severe Grave's Ophthalmopathy: a Prospective Study
This study is testing new surgical techniques to see if they can safely help people with moderate-to-severe Graves' eye disease feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06588764 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of modified deep lateral wall decompression and medial wall decompression techniques for treating moderate-to-severe Graves' ophthalmopathy. The goal is to evaluate the effectiveness of these surgical approaches and identify any complications that may arise. By developing a standardized technical approach, the study aims to improve treatment outcomes for patients suffering from this condition.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate-to-severe thyroid-associated ophthalmopathy who have stable thyroid function.
Not a fit: Patients with other eye diseases or systemic conditions that could complicate surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved surgical outcomes and quality of life for patients with moderate-to-severe Graves' ophthalmopathy.
How similar studies have performed: Other studies have explored surgical interventions for Graves' ophthalmopathy, indicating potential for success with similar approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Hua sheng Yang, M.D,PHD
- Email: yanghs64@162.com
- Phone: +8620-87331539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.