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.
Full Title of Study: “Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 1, 2022
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
5. Biopsy of lacrimal gland denoting a specific diagnosis (i.e. the term "idiopathic" does not apply)
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.
- Drug: Prednisolone
- Oral Tablet
- Drug: Triamcinolone + Betamethason
- A compound long acting and short acting injectable steroid
Arms, Groups and Cohorts
- Experimental: 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.
- Active Comparator: 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.
Clinical Trial Outcome Measures
- Recurrence number
- Time Frame: up to 6 months
- frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
- Recurrence time
- Time Frame: up to 6 months
- mean time of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy
- Adverse Effect
- Time Frame: up to 6 months
- Any significant ocular or systemic side effect reported by the patient or found in examination sessions
Participating in This Clinical Trial
- 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
- Diabetes Mellitus
Gender Eligibility: All
Minimum Age: 15 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Iran University of Medical Sciences
- Tehran University of Medical Sciences
- Provider of Information About this Clinical Study
- Overall Official(s)
- Mohsen B Kashkouli, MD, Principal Investigator, Iran University of Medical Sciences
- Overall Contact(s)
- Mohsen B Kashkouli, MD, 00989121777003, firstname.lastname@example.org
Swamy BN, McCluskey P, Nemet A, Crouch R, Martin P, Benger R, Ghabriel R, Wakefield D. Idiopathic orbital inflammatory syndrome: clinical features and treatment outcomes. Br J Ophthalmol. 2007 Dec;91(12):1667-70. Epub 2007 Jul 9.
Bijlsma WR, Paridaens D, Kalmann R. Treatment of severe idiopathic orbital inflammation with intravenous methylprednisolone. Br J Ophthalmol. 2011 Aug;95(8):1068-71. doi: 10.1136/bjo.2010.195552. Epub 2011 Feb 24.
Citations Reporting on Results
El Nasser A Mohammad A. Local steroid injection for management of different types of acute idiopathic orbital inflammation: an 8-year study. Ophthalmic Plast Reconstr Surg. 2013 Jul-Aug;29(4):286-9. doi: 10.1097/IOP.0b013e318293750c.
Leibovitch I, Prabhakaran VC, Davis G, Selva D. Intraorbital injection of triamcinolone acetonide in patients with idiopathic orbital inflammation. Arch Ophthalmol. 2007 Dec;125(12):1647-51.
Reggie S, Neimkin M, Holds J. Intralesional corticosteroid injections as treatment for non-infectious orbital inflammation. Orbit. 2018 Feb;37(1):41-47. doi: 10.1080/01676830.2017.1353110. Epub 2017 Sep 5.
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