Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

Study Overview
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Brief Summary
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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
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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). Patients in injection group will receive 1 shot of 1 mL (20 mg Triamcinolone + 3 mg Betamethason) into the lacrimal gland.

Official Title
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Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial

Conditions
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Orbital Pseudotumor

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Triamcinolone + Betamethason


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis Exclusion Criteria: Abnormal thyroid-stimulating hormone Systemic Vasculitides Bilateral Orbital Inflammation Collagen Vascular Diseases One Seeing Eye Glaucoma Diabetes Mellitus

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel double arm
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraorbital injection of steroid<br>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. | Drug: Triamcinolone + Betamethason<br>* A compound long acting and short acting injectable steroid<br>* Other names: Injectable Steroid;|
| Active Comparator: Oral Steroid<br>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. | Drug: Prednisolone<br>* Oral Tablet<br>* Other names: Oral Prednisolone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence number | frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy | up to 6 months | 
| Recurrence time | mean time of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy | up to 6 months | 
| Adverse Effect | Any significant ocular or systemic side effect reported by the patient or found in examination sessions | up to 6 months |