The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
研究概览
简要总结
The association of radioiodine therapy for the treatment of thyroid cancer with nasolacrimal duct obstruction has been well documented in the medical literature. Prior case reports have documented radioactive iodine detection in the tears of patients following radioiodine therapy. It is possible that radioactive uptake by the cells in the lacrimal sac and nasolacrimal duct lead to inflammation, fibrosis, and obstruction of the tear duct over time. A recent study has shown that the administration of artificial tears decreases the level of detectable radioiodine in the tears of patients undergoing radioiodine therapy for thyroid cancer. The purpose of this study will be to assess whether administering tears after radioactive iodine therapy for thyroid cancer decreases the incidence of nasolacrimal duct obstruction in the two years following radioactive iodine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Radio-iodine therapy for thyroid cancer
- •Radioiodine therapy ≥150 mCi
- •Age 18 or older
排除标准
- •Use of eye drops, other than artificial tears
- •History of periocular trauma with tear duct involvement/lacrimal gland trauma
- •History of lacrimal drainage disease: canaliculitis, dacryocystitis
- •Prior radiotherapy
- •Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel)
- •Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia)
- •Nasolacrimal duct obstruction at baseline
研究组 & 干预措施
Experimental Arm (Artificial Tears)
Participants in this arm will receive artificial tears to be administered in the 4 days immediately following radioactive iodine therapy. The schedule of administration will be as follows:
Day 1 (day of radioactive iodine therapy): Every 15 minutes for 2 hours, then every 30 minutes for at least 4 hours or until bedtime at night Day 2: Once every 1 hour for 12 hours Day 3: Four times (approximately morning, lunch, dinner, and evening) Day 4: Two times (morning and evening)
干预措施: Artificial Tears Methylcellulose (Drug)
结局指标
主要结局
Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)
时间窗: 2 years
The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.
次要结局
未报告次要终点
研究者
Rachel Sobel
Associate Professor of Ophthalmology
Vanderbilt University Medical Center