Orbital Pseudotumor
Conditions
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.
Interventions
DRUGPrednisolone
Oral Tablet
DRUGTriamcinolone + Betamethason
A compound long acting and short acting injectable steroid
Sponsors
Tehran University of Medical Sciences
Mashhad University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Iran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized parallel double arm
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence number | up to 6 months | frequency of occurrence of clinical condition showing signs of inflammation recurrence, during or after cessation of steroid therapy |
| 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 |
| Adverse Effect | up to 6 months | Any significant ocular or systemic side effect reported by the patient or found in examination sessions |
Countries
Iran
Contacts
Primary ContactMohsen B Kashkouli, MD
Backup ContactNasser Karimi, MD
Outcome results
None listed