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临床试验/NCT01250457
NCT01250457撤回4 期

Topical Timolol for the Treatment of Benign Vascular Periocular Lesions

Loyola University1 个研究点 分布在 1 个国家开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
lesion resolution

研究概览

简要总结

The purpose of this research is to find out if the use of topical timolol 0.5% solution applied twice daily will help to shrink rosacea lesions around the eye.

详细描述

Benign vascular tumors of the eyelid are common causes of ocular morbidity. Capillary hemangiomas in children cause refractive and occlusive amblyopia. In adults, Rosacea-associated eyelid telangiectasis and sclerosis can result in keratitis and corneal neovascularization. Corticosteroid therapy of benign vascular lesions risks sight-threatening complications including central retinal artery occlusion and significant systemic morbidity. Alternatively, oral and intravenous beta-blockers have been reported to induce regression of benign vascular lesions. One recent report documented efficacy of topical timolol in treating a large capillary hemangioma of the eyelid in a child. Topical application reduces systemic side effects of beta-blockers including bradycardia, hypotension, heart block, and bronchospasm. This one-year prospective case-control series will investigate whether topical Timolol 0.5% solution applied twice daily causes significant regression of benign vascular periocular lesions.

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

入选标准

  • Presence of a benign vascular periocular lesion

排除标准

  • Allergy to timolol or beta-blocker class of drugs
  • Lesion characteristics concerning for atypia or malignancy including madarosis, ulceration, and recurrence after previous surgery.
  • Intraocular Pressure less than 10 mm Hg

研究组 & 干预措施

Topical timolol

Experimental

topical Timolol 0.5% solution applied twice daily

干预措施: topical Timolol (Drug)

结局指标

主要结局

lesion resolution

时间窗: 1 year

Pre-treatment and post-treatment lesion size will then be compared to determine whether twice-daily topical application of timolol 0.5% solution alters the morphometry of benign vascular periocular lesions.

次要结局

未报告次要终点

研究者

发起方
Loyola University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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