Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation
- Conditions
- Orbital Pseudotumor
- Interventions
- Registration Number
- NCT03958344
- Lead Sponsor
- Iran University of Medical Sciences
- Brief Summary
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.
- Detailed Description
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:
1. Age \< 15 years
2. Diabetes mellitus
3. Collagen Vascular Diseases
4. Vasculitides
5. Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
6. Glaucoma
7. Patients who have lost one eye
8. Bilateral disease
9. 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).
Patients in injection group will receive 1 shot of 1 mL (20 mg Triamcinolone + 3 mg Betamethason) into the lacrimal gland.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis
- Abnormal thyroid-stimulating hormone
- Systemic Vasculitides
- Bilateral Orbital Inflammation
- Collagen Vascular Diseases
- One Seeing Eye
- Glaucoma
- Diabetes Mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intraorbital injection of steroid Triamcinolone + Betamethason 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. Oral Steroid Prednisolone 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.
- Primary Outcome Measures
Name Time Method Recurrence time 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 up to 6 months frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
Adverse Effect up to 6 months Any significant ocular or systemic side effect reported by the patient or found in examination sessions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Iran University of Medical Sciences
🇮🇷Tehrān, Tehran, Iran, Islamic Republic of