Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recurrence time
研究概览
简要总结
A multicenter randomised double-arm clinical trial, to compare safety and efficacy of oral versus intralesional injection of steroid in a group of patients suffering from idiopathic orbital inflammation is designed. Outcome measures include number of recurrences, duration of remission, and side effects.
详细描述
Expected to be finished in 3 years, patient enrollment includes 59 patient in each arm of the study. Inclusion criteria consist of clinical and/or imaging evidence of dacryoadenitis with or without adjacent rectus muscles (superior and inferior recti) myositis. Patients meeting following conditions will be excluded:
- Age < 15 years
- Diabetes mellitus
- Collagen Vascular Diseases
- Vasculitides
- Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
- Glaucoma
- Patients who have lost one eye
- Bilateral disease
- Abnormal thyroid-stimulating hormone
Outcome measures include number of recurrences, duration of remission, and side effects.
Patient allocation will be based on blocks of 4. Each patient will undergo lacrimal gland biopsy and subsequently will be allocated to one arm of the study according to a predetermined randomization sequence (balanced block of four). Outcome measures will be recorded in 0, 3 and 6 months after patient enrollment.
Patients in oral steroid group will receive 1 mg/kg/day of Prednisolone, tapered in 3 months (based on a detailed table).
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis
排除标准
- •Abnormal thyroid-stimulating hormone
- •Systemic Vasculitides
- •Bilateral Orbital Inflammation
- •Collagen Vascular Diseases
- •One Seeing Eye
- •Diabetes Mellitus
研究组 & 干预措施
Intraorbital injection of steroid
2 mL of steroid will be ready for each injection session:
1 mL Triamcinolone (40 mg) + 1 mL Betamethasone (6 mg) = 2 mL
For Dacryoadenitis without myositis , 1 mL of this compound will be injected at lacrimal gland through 1 site of injection.
For Dacryoadenitis plus 1 rectus muscles myositis 1 mL of this compound will be injected at lacrimal gland and 0.5 mL of this compound will be injected at the rectus muscle through 2 separate sites of injection.
For Dacryoadenitis plus 2 rectus muscles myositis 1 mL of this compound will be injected at lacrimal gland and 0.5 mL of this compound will be injected at either recti muscles through 3 separate sites of injection.
干预措施: Triamcinolone + Betamethason (Drug)
Oral Steroid
Each patient will receive oral Prednisolone, 1 mg/kg, for 5-7 days, followed by tapered dose in 12 weeks (according to a pre-defined table of oral administration dose).
Daily Omeprazole 40mg p.o and daily Calcium Supplement will also be recommended to avoid complications.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Recurrence time
时间窗: up to 6 months
mean time of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
Recurrence number
时间窗: up to 6 months
frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
Adverse Effect
时间窗: up to 6 months
Any significant ocular or systemic side effect reported by the patient or found in examination sessions
次要结局
未报告次要终点