Comparing injections and oral steroids for orbital inflammation treatment
Intraorbital Injection Versus Oral Steroid in Patients With Anterior Idiopathic Orbital Inflammation: A Randomized Clinical Trial
This study is testing whether taking oral steroids or getting steroid injections is better for treating orbital inflammation in people with orbital pseudotumor.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Iran University of Medical Sciences Academic / other |
| Locations | 1 site (Tehrān, Tehran) |
| Trial ID | NCT03958344 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a multicenter, randomized, double-arm study designed to compare the safety and efficacy of oral steroids versus intralesional steroid injections in patients with idiopathic orbital inflammation, specifically orbital pseudotumor. The trial will enroll 118 patients, with 59 in each treatment arm, and will assess outcomes such as recurrence rates, duration of remission, and side effects over a period of six months. Patients will undergo a lacrimal gland biopsy for diagnosis and will be randomly assigned to one of the two treatment groups. The oral steroid group will receive a tapering dose of Prednisolone, while the injection group will receive a single dose of Triamcinolone combined with Betamethasone.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 15 years and older with clinical or imaging evidence of dacryoadenitis with or without adjacent rectus muscle myositis.
Not a fit: Patients with conditions such as diabetes mellitus, glaucoma, or bilateral orbital inflammation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from orbital pseudotumor, potentially reducing recurrence rates and improving quality of life.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of injection versus oral steroids in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tehrān, Tehran
- Iran University of Medical Sciences — Tehrān, Tehran, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Mohsen B Kashkouli, MD — Iran University of Medical Sciences
- Study coordinator: Mohsen B Kashkouli, MD
- Email: mkashkouli2@gmail.com
- Phone: 00989121777003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.