Tamsulosin for Thyroid Lid Retraction

Thyroid Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359979
• Other study ID #: SHEBA-20-7022-OS-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2022
• Source: Sheba Medical Center
• Contact: Oded Sagiv, MD
• Phone: 97235302874
• Email: Oded.Sagiv[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Diseases
• Eyelid Diseases
• Graves Ophthalmopathy
• Thyroid Diseases
• Thyroid Eye Disease

Intervention

Drug:
• Tamsulosin
selective alpha1 receptor antagonist

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Esmaeli-Gutstein B, Hewlett BR, Pashby RC, Oestreicher J, Harvey JT. Distribution of adrenergic receptor subtypes in the retractor muscles of the upper eyelid. Ophthalmic Plast Reconstr Surg. 1999 Mar;15(2):92-9. — View Citation

Kikuchi-Utsumi K, Ishizaka M, Matsumura N, Nakaki T. Alpha(1A)-adrenergic control of piloerection and palpebral fissure width in rats. Auton Neurosci. 2013 Dec;179(1-2):148-50. doi: 10.1016/j.autneu.2013.04.011. Epub 2013 May 20. — View Citation

Yano S, Hirose M, Nakada T, Nakayama J, Matsuo K, Yamada M. Selective alpha 1A-adrenoceptor stimulation induces Mueller's smooth muscle contraction in an isolated canine upper eyelid preparation. Curr Eye Res. 2010 May;35(5):363-9. doi: 10.3109/02713680903518858. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eyelid retraction	measuring the upper margin to reflex distance (MRD1)	1 week after starting tamsulosin treatment
Primary	eyelid retraction	measuring the upper margin to reflex distance (MRD1)	1 month after starting tamsulosin treatment
Primary	eyelid retraction	measuring the upper margin to reflex distance (MRD1)	3 months after starting tamsulosin treatment