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A Prospective Randomized Controlled Trial Comparing Endonasal Versus Orbital Approach Orbital Decompression for Visual Improvement in Patients with Extremely Severe Thyroid Eye Disease

A Prospective Randomized Controlled Trial Comparing Endonasal Versus Orbital Approach Orbital Decompression for Visual Improvement in Patients with Extremely Severe Thyroid Eye Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128920
Enrollment
Unknown
Registered
2026-07-28
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Severe Thyroid Eye Disease

Interventions

Transorbital approach:Transorbital Orbital Decompression for Patients with Extremely Severe Thyroid Eye Disease
Endonasal approach:Endonasal Orbital Decompression in Extremely Severe TED

Sponsors

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 years old or above, no gender restrictions; 2.Meeting the diagnostic criteria for extremely severe thyroid eye disease (TED); 3.Failure to respond to or intolerance of conservative treatments (including glucocorticoids, radiotherapy, etc.); 4.Stable euthyroid status within the past six months (including patients under pharmacological control); 5.Voluntary signing of the surgical informed consent form by the patient;

Exclusion criteria

Exclusion criteria: 1.Patients with surgical contraindications including severe cardiac, hepatic or renal insufficiency (myocardial ischemia, myocardial infarction, arrhythmia, cardiac dysfunction), etc. 2.Patients with diabetes mellitus or other autoimmune diseases, uncontrolled hypertension, tuberculosis, or psychiatric disorders; 3.Patients with positive pregnancy test results; 4.Patients whose clinical conditions are unsuitable for combined medial and inferior orbital wall decompression; 5.Candidates planned for the endonasal approach who cannot undergo endoscopic surgery due to abnormal nasal cavity anatomy;

Design outcomes

Primary

MeasureTime frame
visual activity;

Secondary

MeasureTime frame
Operative time;Hospitalization cost;Globe retrodisplacement;Improvement in visual field defect;Ocular motility range;Change in prism diopter deviation;Improvement in diplopia score;

Countries

China

Contacts

Public ContactHuifang Zhou

Shanghai Ninth Peoples Hospital,Shanghai JiaoTong University School of Medicine

fangzzfang@163.com+86 13661901886

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026