Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial
Who is this study for? Patients with anterior idiopathic orbital inflammation
Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:
• Dacryoadenitis based on clinical findings and/or imaging with and without adjacent recti muscle myositis
Locations
Other Locations
Islamic Republic of Iran
Iran University of Medical Sciences
RECRUITING
Tehrān
Contact Information
Primary
Mohsen B Kashkouli, MD
mkashkouli2@gmail.com
00989121777003
Backup
Nasser Karimi, MD
karimi.na@iums.ac.ir
+989123272376
Time Frame
Start Date: 2022-01-01
Completion Date: 2025-06-01
Participants
Target number of participants: 120
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Iran University of Medical Sciences
Collaborators: Tehran University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Mashhad University of Medical Sciences