Tamsulosin for Thyroid Lid Retraction

Sheba Medical Center

Status: Enrolling

Conditions: Thyroid Eye Disease; Eyelid Diseases

Treatments: Drug: Tamsulosin

Study type: Interventional

Funder types: Other

Identifiers

NCT04359979

SHEBA-20-7022-OS-CTIL

Details and patient eligibility

About

The purpose of this study is to examine the effect of using Tamsulosin for treatment of eyelid retraction as part of thyroid eye disease. The treatment will be offered to all thyroid patients suffering from eyelid retraction who are treated at the thyroid clinic in Sheba's Ophthalmology department. All patient will receive information about the drug Tamsulosin, the possible side effects, and the alternative treatment options for retraction.

Patients recruited will take 0.4mg/day Tamsulosin for 3 months and will have follow-ups at 1 week, 1 month and 3 months to evaluate the retraction status.

Full description

Thyroid eye disease is a common autoimmune disorder caused by antibodies directed against receptors present in the thyroid cells and extra-ocular muscles and soft tissue of the orbit. The disorder is characterised by enlargement of the extra-ocular muscles, fatty and connective tissue volume.

Upper lid retraction is the most common sign of the eye disease (present in up to 92%). The causes for retraction are not fully understood. It may be related to inflammation of the Levator muscle and the Muller muscle, or related to over sympathetic activity causing overstimulation of the Muller muscle.

Upper lid retraction severity can range from very light to severe, with scleral show, eye dryness and even exposure keratopathy. Additionally it can have a very significant effect on the patient's appearance (a constant surprised look).

Treatments for lid retraction include aggressive lubrication and tarsorrhaphy if needed (sewing the eyelids together).

The Muller is a smooth muscle which elevates the upper eyelid and is sympathetically innervated (alpha receptor).

The drug Tamsulosin which is a selective alpha1 receptor antagonist is commonly used today for benign prostatic hyperplasia (relaxing the prostate muscle).

In this study we would like to test using Tamsulosin for treatment of lid retraction caused by thyroid eye disease. We hypothesise that the relaxation of the Muller muscle may have a beneficial effect on the retraction.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thyroid eye disease patients suffering from upper eyelid retraction in one or both eyes

Exclusion criteria

• pregnant/breastfeeding women
• previous eyelid surgery/trauma

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

tamsulosin treatment

Experimental group

Description:

patients will receive 0.4mg/day of Tamsulosin tablet for 3 months

Treatment:

Drug: Tamsulosin