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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04976816 on ClinicalTrials.gov