NCT03958344

Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Iran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orbital Pseudotumor

Interventions

Type	Name	Description
DRUG	Prednisolone	Oral Tablet
DRUG	Triamcinolone + Betamethason	A compound long acting and short acting injectable steroid

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2019-05-22
• Last updated: 2023-02-16

Locations

1 site across 1 country: Iran