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临床试验/NCT01579344
NCT01579344Unknown不适用

Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Fabricio Lopes da Fonseca1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1

研究概览

简要总结

The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature.

Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients.

It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • Thyroid carcinoma
  • Previous thyroidectomy

排除标准

  • Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic)
  • Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL
  • Lacrimal gland / ocular trauma
  • Radiation therapy for other diseases or radiotherapy of head and neck
  • Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.

研究组 & 干预措施

Thyroid carcinoma, Radioactive iodine therapy

Active Comparator

50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma undergoing radioactive iodine therapy

干预措施: Radioiodine therapy (Drug)

研究者

发起方
Fabricio Lopes da Fonseca
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fabricio Lopes da Fonseca

Principal Investigator

University of Sao Paulo

研究点 (1)

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