Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04976816

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Eye Disease	Procedure: peri-levator betamethasone injection Procedure: peri-levator triamcinolone injection Procedure: peri-levator and retrobulbar betamethasone injection Procedure: peri-levator and retrobulbar triamcinolone injection	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1 peri-levator betamethasone injection patients with isolated thyroid-related upper lid retraction who will be given the Peri-levator injection of betamethasone suspension	Procedure: peri-levator betamethasone injection The injection dose will be 1.5 ml of betamethasone suspension (1 ml contains 5 mg betamethasone dipropionate &2 mg betamethasone sodium phosphate). The needle will be introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where the injection is delivered. The injection will be repeated every 4-6 weeks according to the clinical response up to 3 injections.
Experimental: A2 Peri-levator triamcinolone acetate injection patients with isolated thyroid-related upper lid retraction who will be given Peri-levator injection of triamcinolone acetate	Procedure: peri-levator triamcinolone injection The needle will be introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where 1ml (40mg/ml) triamcinolone acetate is injected. The injection will be repeated every 4-6 weeks according to the clinical response up to 3 injections.
Experimental: B1 Peri-levator and retrobulbar betamethasone injection patients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of betamethasone suspension	Procedure: peri-levator and retrobulbar betamethasone injection In addition to peri-levator betamethasone injection for UER, a retrobulbar injection for proptosis will be given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
Experimental: B2 Peri-levator and retrobulbar triamcinolone acetate injection patients with thyroid-related upper lid retraction and proptosis who will be given Peri-levator and retrobulbar injection of triamcinolone acetate	Procedure: peri-levator and retrobulbar triamcinolone injection In addition to peri-levator triamcinolone injection for UER, a retrobulbar injection for proptosis will be given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.

Outcome Measures

Primary Outcome Measures

to measure the change in MRD1 in mm using a ruler in all groups after peri-levator injection of different types of steroid [2 minutes]
The technique will be considered; 1) Effective if the MRD1 reaches the normal value< or= 4mm, 2) Partially effective if the MRD1 is improved but do not reach the normal values, 3) Ineffective if no improvement occur in MRD1
to measure the change in proptosis in mm using Hertel's exophthalmometer in group B after retrobulbar injection of different types of steroid [4 minutes]
The technique will be considered; 1) Effective if the reading of Hertel's exophthalmometer reaches the normal value (16±2mm), 2) Partially effective if the proptosis is improved but do not reach the normal values, 3) Ineffective of no improvement occur in proptosis

Secondary Outcome Measures

to document any change in size of superior rectus levator complex and other extra-ocular muscles [4 minutes]
measuring size of superior rectus levator complex and other extra-ocular muscles before and after injections by orbital imaging techniques (CT or MRI).