Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid-Related Upper Lid Retraction With and Without Proptosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- to measure the change in proptosis in mm using Hertel's exophthalmometer in group B after retrobulbar injection of different types of steroid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Thyroid Eye Disease.
- •Thyroid function within normal range.
排除标准
- •Patients on systemic steroid and or immunosuppressive therapy.
- •Patients underwent thyroidectomy.
- •Sight threatening (severe) TED which requires immediate surgery.
- •Patients with fibrotic ocular muscles who need surgery.
- •Contraindications to steroid therapy as in pregnant women.
结局指标
主要结局
to measure the change in proptosis in mm using Hertel's exophthalmometer in group B after retrobulbar injection of different types of steroid
时间窗: 4 minutes
The technique will be considered; 1) Effective if the reading of Hertel's exophthalmometer reached the normal value (16±2mm), 2) Partially effective if the proptosis was improved but did not reach the normal values, 3) Ineffective of no improvement occured in proptosis
to measure the change in MRD1 in mm using slit lamp biomicroscope in all groups after peri-levator injection of different types of steroid
时间窗: 2 minutes
The technique was considered; 1) Effective if the MRD1 reached the normal value\< or= 4.5mm, 2) Partially effective if the MRD1 was improved but did not reach the normal values, 3) Ineffective if no improvement occured in MRD1
次要结局
- to document any change in size of superior rectus levator complex and other extra-ocular muscles(4 minutes)
研究者
Rawda Abdelnaser
assistant lecturer
Assiut University
