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Comparison of Orbital Decompression with Transnasal Approach and Transorbital Approach in Patients with Thyroid Eye Disease: A Randomized Clinical Trial

Comparison of Orbital Decompression with Transnasal Approach and Transorbital Approach in Patients with Thyroid Eye Disease: A Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013268
Enrollment
Unknown
Registered
2017-11-03
Start date
2017-11-01
Completion date
Unknown
Last updated
2017-11-13

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

Conditions

Thyroid eye disease

Interventions

1:Transnasal decompression surgery
2:Transorbital decompression surgery

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-70 years old, male or female; 2. Diagnosed with TED; 3. Underwent orbital decompression due to disfiguring proptosis, exposure keratitis or DON 4. Normalized thyroid function for at least 3 months before included: including those who are taking anti hyperthyroidism drugs or without taking medication, FT3, FT4 normal, TSH normal or lower; 5. CAS score = 3 points and unchanged proptosis (changes =1mm between 2 visits) for at least 3 months; 6. Proptosis =18 mm.

Exclusion criteria

Exclusion criteria: 1. Severe disease of heart, liver and kidney function failure including myocardial ischemia or myocardial infarction, arrhythmia and heart failure; ALT, AST more than 1.5 times the upper limit of the normal value; creatinine level over normal limit or eGFR < 60 ml/min/1.73 M2); 2. Diabetes or other autoimmune diseases, uncontrolled hypertension, tuberculosis, mental disease patients; 3. Patients with positive pregnancy test; 4. Patients with abnormal nasal structure; 5. Other reasons leading to contraindications to surgery.

Design outcomes

Primary

MeasureTime frame
Postoperative proptosis reduction;

Secondary

MeasureTime frame
Diplopia and Strabismus;Ocular restriction;Visual acuity;Surgical time;hospital day;

Countries

China

Contacts

Public ContactHuifang Zhou

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

fangzzfang@163.com+86 18918526205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026