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Endoscopic Transethmoidal Orbital Decompression Combined with One-Stage Strabismus Correction Surgery for TAO with Horizontal Strabismus: A Multicenter, Randomized, Controlled Trial

Endoscopic Transethmoidal Orbital Decompression Combined with One-Stage Strabismus Correction Surgery for TAO with Horizontal Strabismus: A Multicenter, Randomized, Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125972
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Thyroid-associated ophthalmopathy

Interventions

combined group:Orbital decompression with strabismus correction surgery
staged group:First undergo orbital decompression surgery, followed by strabismus correction surgery again 3–6 months postoperatively.

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.A diagnosis of TAO; 2.Age >=18 years; 3.Limited eye movement secondary to TAO; 4.Stable degree of strabismus for at least 3 months prior to surgery; 5.Stable thyroid function for at least 6 months prior to surgery; 6.In an inactive phase of the disease (CAS score =3/7);

Exclusion criteria

Exclusion criteria: 1.The strabismus is caused by any other factor; 2.The presence of congenital eye diseases or developmental abnormalities that affect extraocular muscle function, such as congenital fibrosis of the extraocular muscles; 3.Previous eyelid or orbital surgery; 4.History of ocular trauma with incomplete recovery; 5.Unstable thyroid function, receipt of pulse steroid therapy, I-131 therapy, or orbital radiotherapy within the past six months; 6.TAO patients with sight-threatening conditions requiring urgent orbital surgery (optic nerve involvement,corneal ulcer); 7.Concomitant with other vision-affecting eye diseases, such as glaucoma, severe media opacities, retinal detachment, maculopathy, and optic neuropathy; 8.Presence of ocular infectious diseases, such as conjunctivitis, keratitis, endophthalmitis; 9.Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg), unstable angina, recent myocardial infarction; 10.Uncontrolled diabetes mellitus (fasting blood glucose >6 mmol/L and/or glycated hemoglobin >9%); severe hepatic and renal insufficiency, abnormal liver and kidney function. 11.Active autoimmune diseases (other than TAO), such as systemic lupus erythematosus, rheumatoid arthritis; 12.Presence of coagulation disorders or current use of medications that affect coagulation function (such as warfarin, aspirin) that cannot be discontinued. 13.History of malignant tumor and currently undergoing radiotherapy or chemotherapy; 14.Other physical conditions that preclude surgical treatment, such as pregnant/lactating women, history of psychiatric disorders, history of drug addiction;

Design outcomes

Primary

MeasureTime frame
Eye movement;HRCT;Vision field;Vision acuity;Synoptophore;Slit lamp and fundus lens;Stereopsis;Intraocular pressure;Exophthalmos;

Secondary

MeasureTime frame
CAS score;OCT and OCTA examination;Physical examination;ECG;GO-QoL;Severity assessment;Ocular alignment examination;Blood;Vital signs;Binocular Visual Function Test;

Countries

China

Contacts

Public ContactYunhai Tu

Eye Hospital, Wenzhou Medical University

tyh5@21cn.com+86 577 8806 8861

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026