Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation
NCT ID: NCT03958344
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2022-01-01
2025-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Triamcinolone + Betamethason
A compound long acting and short acting injectable steroid
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.
Prednisolone
Oral Tablet
Interventions
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Prednisolone
Oral Tablet
Triamcinolone + Betamethason
A compound long acting and short acting injectable steroid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Systemic Vasculitides
* Bilateral Orbital Inflammation
* Collagen Vascular Diseases
* One Seeing Eye
* Glaucoma
* Diabetes Mellitus
15 Years
ALL
No
Sponsors
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Tehran University of Medical Sciences
OTHER
Mashhad University of Medical Sciences
OTHER
Shahid Beheshti University of Medical Sciences
OTHER
Iran University of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Mohsen B Kashkouli, MD
Role: PRINCIPAL_INVESTIGATOR
Iran University of Medical Sciences
Locations
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Iran University of Medical Sciences
Tehrān, Tehran Province, Iran
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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. doi: 10.1001/archopht.125.12.1647.
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.
Other Identifiers
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IR.IUMS.REC.1397.1202
Identifier Type: -
Identifier Source: org_study_id
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