Intraorbital Injection Versus Oral Steroid in Anterior Idiopathic Orbital Inflammation

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    120
  • sponsor
    Iran University of Medical Sciences
Updated on 8 July 2021

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.

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.

Details
Condition Orbital Pseudotumor
Treatment Prednisolone, Triamcinolone + Betamethason
Clinical Study IdentifierNCT03958344
SponsorIran University of Medical Sciences
Last Modified on8 July 2021

Eligibility

Yes No Not Sure

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
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