Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy

Sun Yat-sen University

Status: Unknown

Conditions: Thyroid Associated Ophthalmopathy

Treatments: Procedure: combination of orbital compression surgery and strabismus surgery; Procedure: orbital compression

Study type: Interventional

Funder types: Other

Identifiers

NCT04919694

yanghs20210106

Details and patient eligibility

About

The purpose of this study is to determine whether combination of orbital compression surgery with strabismus surgery is better than strabismus surgery after orbital compression surgery in the treatment of moderate-to-severe thyroid associated ophthalmopathy

Full description

This study will be a interventional case series. Patients with moderate-to-severe thyroid associated ophthalmopathy will be randomized to receive combination of orbital compression surgery with strabismus surgery or strabismus surgery after orbial compression surgery.Patients will be followed for 6 months.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderate-to-severe thyroid associate ophthalmopathy
• CAS≤3 score
• monocular strabismus,deviation≥20° or 35▲
• stable thyroid function for at least 6 months, confirmed by an endocrinologist

Exclusion criteria

• any previous disease in the study eye.
• any previous systematic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

combination of orbital compression and strabismus surgery

Experimental group

Description:

orbital compression and strabismus surgery are performed at the same time

Treatment:

Procedure: combination of orbital compression surgery and strabismus surgery

perform strabismus surgery after orbital compression

Active Comparator group

Description:

Firstly, perform orbital compression, after about 3 to 6 months ,strabismus surgery is done.

Treatment:

Procedure: orbital compression