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| Name | Class |
|---|---|
| Tehran University of Medical Sciences | OTHER |
| Mashhad University of Medical Sciences | OTHER |
| Shahid Beheshti University of Medical Sciences | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraorbital injection of steroid | Experimental | 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. |
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| Oral Steroid | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Oral Tablet |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohsen B Kashkouli, MD | Contact | 00989121777003 | mkashkouli2@gmail.com | |
| Nasser Karimi, MD | Contact | +989123272376 | karimi.na@iums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Mohsen B Kashkouli, MD | Iran University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iran University of Medical Sciences | Recruiting | Tehrān | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17620331 | Background | 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. doi: 10.1136/bjo.2007.124156. Epub 2007 Jul 9. | |
| 21349945 | Background | 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. |
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| ID | Term |
|---|---|
| D016727 | Orbital Pseudotumor |
| ID | Term |
|---|---|
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Randomized parallel double arm
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| Triamcinolone + Betamethason | Drug | A compound long acting and short acting injectable steroid |
|
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| 23839634 | Result | 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. |
| 18071116 | Result | 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. doi: 10.1001/archopht.125.12.1647. |
| 28872378 | Result | 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. |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |