Treatment With Tamsulosin for Upper Eyelid Retraction Related to Thyroid Eye Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- eyelid retraction
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thyroid eye disease patients suffering from upper eyelid retraction in one or both eyes
排除标准
- •pregnant/breastfeeding women
- •previous eyelid surgery/trauma
研究组 & 干预措施
tamsulosin treatment
patients will receive 0.4mg/day of Tamsulosin tablet for 3 months
干预措施: Tamsulosin (Drug)
结局指标
主要结局
eyelid retraction
时间窗: 3 months after starting tamsulosin treatment
measuring the upper margin to reflex distance (MRD1)
次要结局
未报告次要终点
研究者
Dr. Oded Sagiv
Principal Investigator
Sheba Medical Center