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Search / Trial NCT06588764

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

Launched by SUN YAT-SEN UNIVERSITY · Sep 5, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a specific type of surgery called modified orbital decompression to help treat people with moderate to severe Graves' ophthalmopathy, a condition that can cause bulging eyes and other eye problems due to thyroid issues. The researchers want to see how effective and safe this surgery is for improving symptoms in patients. If you or someone you know has been diagnosed with this condition and is between the ages of 18 and 75, you might be eligible to participate. To qualify, participants need to have stable thyroid levels for at least six months and a certain level of eye symptoms.

If you decide to join the trial, you will undergo surgery and be monitored closely by the medical team. They will check how well the surgery works and keep an eye on any side effects. It's important to note that individuals with serious other health problems or certain eye diseases may not be eligible to participate. This study aims to provide valuable information on how this surgery can help improve quality of life for those affected by Graves' ophthalmopathy.

Gender

ALL

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

About Sun Yat Sen University

Sun Yat-sen University, a prestigious institution located in Guangzhou, China, is dedicated to advancing medical research and healthcare innovations. As a leading clinical trial sponsor, the university leverages its extensive academic resources and collaboration with top-tier medical professionals to conduct rigorous clinical studies. Committed to improving patient outcomes and contributing to global health knowledge, Sun Yat-sen University focuses on a wide range of therapeutic areas, employing cutting-edge methodologies to ensure the integrity and efficacy of its research initiatives. Through its clinical trials, the university aims to foster scientific advancements and enhance the quality of care provided to patients both locally and internationally.

Locations

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported