Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease

Thyroid Eye Disease Clinical Trial

Official title: Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis

Status Completed

Clinical Trial Summary

To compare the efficacy of local injections of two different types of steroid (betamethasone suspension versus triamcinolone acetate) in management of patients with thyroid-related upper lid retraction either isolated or associated with proptosis.

Clinical Trial Description

Thyroid Eye Disease (TED) is a complex autoimmune disorder that causes substantial morbidity. It can result in enlargement and scarring of orbital fat and muscles with orbital disfigurement, diplopia, and even vision loss. Although the disease is self-limited following an inflammatory phase of 12 - 18 months, its long-term changes to periocular tissues may have a significant effect on the quality of life, mental health, and socioeconomic status of patients. Most patients with TED (>90%) have Graves' disease, which is an inflammatory autoimmune condition that is caused by thyrotropin (TSH) receptor autoantibodies. Graves' disease is common around the world and it mainly affects middle-aged women with an overall prevalence of 0.5%. Several validated assessment scores are used to assess different components of the disease. The two main current TED classifications are from the European Group on Graves Orbitopathy (EUGOGO); and Vision, Inflammation, Strabismus, Appearance (VISA). EUGOGO has introduced one score for clinical activity (CAS) and one for severity "Clinical Severity Score" (CSS). The baseline CAS asses 7 subjective symptoms and inflammatory signs with 3 additional points in follow-up for increased proptosis, decreased ocular motility, or decreased visual acuity (the CAS 10- point scale). In comparison, CSS evaluates the magnitude of the exophthalmometer or proptosis values, lid retraction, diplopia grades, and corneal involvement. Periorbital inflammation can cause swelling, fatty infiltration, and scarring of the eyelid muscles, resulting in eyelid retraction and upper scleral exposure, which are the most common clinical features of TED. Several treatment options have been described for correction of eyelid retraction (ELR), including local steroid, Botox and filler injection, and surgeries in the fibrotic stage. Although surgical treatment remains an effective option, the outcomes may be unpredictable. In addition, there are some situations where surgery is inappropriate or contraindicated, where temporary or definitive measures are required during the active phase of the disease, or where patients may prefer less invasive options. Systemic steroid therapy is a well-established form of immunosuppressive treatment for TED. There have been reports showing promising results with local steroid injection for the treatment of upper eyelid retraction (UER), There are also some reports about the retrobulbar and periocular injection of steroids for management of proptosis in TED. ;

Related Conditions & MeSH terms

• Eye Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

• NCT number: NCT04976816
• Study type: Interventional
• Source: Assiut University
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2021
• Completion date: October 30, 2023