An interventional study of Tamsulosin in Thyroid Eye Disease and Eyelid Diseases, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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.
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.
740 studies on the registry are indexed under Eye Diseases; 117 are open to participants now.
This study's planned enrollment of 50 is below the median of 68 across 547 interventional studies indexed under Eye Diseases.
Browse Eye Diseases studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
patients will receive 0.4mg/day of Tamsulosin tablet for 3 months
Drug: Tamsulosin
selective alpha1 receptor antagonist
Also known as: Omnic
eyelid retraction
measuring the upper margin to reflex distance (MRD1)
Time frame: 1 week after starting tamsulosin treatment
eyelid retraction
measuring the upper margin to reflex distance (MRD1)
Time frame: 1 month after starting tamsulosin treatment
eyelid retraction
measuring the upper margin to reflex distance (MRD1)
Time frame: 3 months after starting tamsulosin treatment
Plan to share: No
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center