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临床试验/2023-504451-27-00
2023-504451-27-00撤回4 期

Treating socket discharge and discomfort: randomized test of vitamin A ointment, low-dose steroids and artificial tears

Amsterdam UMC1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年6月15日最近更新:

试验速览

阶段
4 期
状态
撤回
发起方
入组人数
100
试验地点
1
主要终点
Change of discomfort score and discharge score and discharge score from baseline till 2-week use of either: Artificial eyedrops, topical vitamin A ointment or low-dose topical steroids

研究概览

简要总结

This study aims to test the effect of artificial tears, vitamin A ointment and steroid drops in artificial eye wearers with chronic complaints of irritation and/or excess discharge.

入排标准

年龄范围
18 years 至 65+ years(65+ Years, 18-64 Years)
接受健康志愿者

入选标准

  • Patients wearing an ocular prosthesis and Excess mucopurulent discharge and/or discomfort

排除标准

  • Subjects < 16 years old - Subjects expected to be incapable to understand the study or fill-out the questionnaires. - Patients with treatable acquired medical issues of the socket (ie new conjunctival cyst, exposed implant). If the patients still have mucopurulent discharge and discomfort after removal/treatment of the irritative factor, they can be included. - Patients with transient complaints from suspected (sub) acute infections for which antibiotics are prescribed. If the patients still have mucopurulent discharge and discomfort after treatment, they can be included. - Patients with scratched, or irregular prostheses, or with latest polishing more than one year ago, should first have their prosthesis polished or renewed. If the patients still have mucopurulent discharge and discomfort after these improvements than they can be included. - The model of the prosthesis should first be adapted if a wrong fit is suspected (ie large empty space, pressure points). If the patients still have mucopurulent discharge and discomfort after these improvements than they can be included.

结局指标

主要结局

Change of discomfort score and discharge score and discharge score from baseline till 2-week use of either: Artificial eyedrops, topical vitamin A ointment or low-dose topical steroids

Change of discomfort score and discharge score and discharge score from baseline till 2-week use of either: Artificial eyedrops, topical vitamin A ointment or low-dose topical steroids

次要结局

  • We also attempt to characterize the patients who will benefit from either artificial eyedrops, topical vitamin A ointemnt of low-dose steroids

研究者

发起方
Amsterdam UMC
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Arthur Liu

Scientific

Amsterdam UMC

研究点 (1)

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