Tamsulosin for Thyroid Lid Retraction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment With Tamsulosin for Upper Eyelid Retraction Related to Thyroid Eye Disease.

Conditions
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Thyroid Eye Disease, Eyelid Diseases

Intervention / Treatment
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* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: off label use of an approved drug for new indication
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tamsulosin treatment<br>patients will receive 0.4mg/day of Tamsulosin tablet for 3 months | Drug: Tamsulosin<br>* selective alpha1 receptor antagonist<br>* Other names: Omnic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eyelid retraction | measuring the upper margin to reflex distance (MRD1) | 1 week after starting tamsulosin treatment | 
| eyelid retraction | measuring the upper margin to reflex distance (MRD1) | 1 month after starting tamsulosin treatment | 
| eyelid retraction | measuring the upper margin to reflex distance (MRD1) | 3 months after starting tamsulosin treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eyelid retraction, tamsulosin, alpha receptor antagonist