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Endo-navi System Assisted Orbital Decompression in Patients with Thyroid Eye Disease: A Multi-center Randomized Clinical Trial

Endo-navi System Assisted Orbital Decompression in Patients with Thyroid Eye Disease: A Multi-center Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016556
Enrollment
Unknown
Registered
2018-06-08
Start date
2018-06-08
Completion date
Unknown
Last updated
2018-06-11

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:Endo-navi System Assisted Orbital Decompression
2:Traditional orbital decompression

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years old; 2. Diagnosed with moderate to severe inactive TED or very severe TED; 3. Proptosis =18mm; 4. With informed consent

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. Axis oculi =24mm.

Design outcomes

Primary

MeasureTime frame
Effective rate in week 13;

Secondary

MeasureTime frame
Vision in week 13;Diplopia in week 13;Ocular restriction in week 13;Surgical Completeness;

Countries

China

Contacts

Public ContactXianqun Fan

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

fanxq@sjtu.edu.cn+86 021-63135606

Outcome results

None listed

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