Local Betamethasone Versus Triamcinolone Injection in Management of Thyroid Eye Disease
NCT04976816 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 92
Last updated 2023-11-14
Summary
To compare the efficacy of local injections of two different types of steroid (betamethasone suspension versus triamcinolone acetate) in management of patients with thyroid-related upper lid retraction either isolated or associated with proptosis.
Conditions
- Thyroid Eye Disease
Interventions
- PROCEDURE
-
peri-levator betamethasone injection
The injection dose was 1 ml of betamethasone suspension (1 ml contains 5 mg betamethasone dipropionate \&2 mg betamethasone sodium phosphate). The needle was introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where the injection was delivered. The injection was repeated every 4 weeks according to the clinical response up to 5 injections.
- PROCEDURE
-
peri-levator triamcinolone injection
The needle was introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where 1ml (40mg/ml) triamcinolone acetate was injected. The injection was repeated every 4 weeks according to the clinical response up to 5 injections.
- PROCEDURE
-
peri-levator and retrobulbar betamethasone injection
In addition to peri-levator betamethasone injection for UER, a retrobulbar injection for proptosis was given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
- PROCEDURE
-
peri-levator and retrobulbar triamcinolone injection
In addition to peri-levator triamcinolone injection for UER, a retrobulbar injection for proptosis was given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
Sponsors & Collaborators
-
Assiut University
lead OTHER
Principal Investigators
-
Ahmed Abdelal, MD · Assiut University
-
Mohamed Shehata, MD · Assiut University
-
Salma Kedwany, MD · Assiut University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-01
- Primary Completion
- 2023-10-01
- Completion
- 2023-10-30
Countries
- Egypt
Study Locations
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