Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System

Study Overview
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Brief Summary
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The purpose of this study is to explore whether administration of preservative free artificial tears will decrease the level of detectable radioiodine in the tears and nasolacrimal duct system of patients undergoing radioiodine therapy for thyroid carcinoma and thus decrease the risk of developing radioactive iodine associated nasolacrimal duct obstruction.

Detailed Description
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Primary Objective: - To assess whether use of preservative free artificial tears following radioactive iodine administration will lower the level of radioactive iodine in the tears of patients treated with radioactive iodine for thyroid carcinoma. Secondary Objective: - To evaluate whether artificial tears would be an effective preventative intervention to decrease the risk of developing nasolacrimal duct stenosis, which has been associated with radioactive iodine administration.

Official Title
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Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma

Conditions
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Thyroid Carcinoma, Radioactive Iodine Level

Intervention / Treatment
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* Drug: Artificial Tears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radio-iodine therapy for thyroid cancer Radioiodine therapy ≥100mCi Patient wears soft contacts on both eyes Exclusion Criteria: 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 Sarcoid Granulomatosis with polyangiitis Chronic lymphocytic leukemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preservative free artificial tears<br>Day 1, patients will self-administer artificial tears every 15 minutes for 2 hours followed by every 30 minutes for at least 4 hours or until bedtime at night. On Day 2, patients will self-administer artificial tears every 1 hour for 12 hours. On Day 3, patients will self-administer artificial tears four times that day. On Day 4, patients will self-administer tears twice that day. Patients will be instructed to wear their contact lenses throughout their waking hours. | Drug: Artificial Tears<br>* Self-Administered - utilizing eye drop preservative free vials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in level of radioactive iodine in tears | Radioactive iodine level will be measured using a well counter through the Nuclear medicine department | about 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the number of eyes that develop nasolacrimal duct stenosis symptoms such as epiphora or tear duct infections | Patients will be monitored over time for development of nasolacrimal duct stenosis symptoms, such as epiphora or tear duct infections. Patients will be be assessed in clinic every 8 months for 2 years after radioactive iodine. They will asked about symptoms related to nasolacrimal duct stenosis and will also received tear duct irrigation. | 2 years |