Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer

Conditions
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Nasolacrimal Duct Obstruction, Thyroid Cancer

Intervention / Treatment
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* Drug: Artificial Tears Methylcellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radio-iodine therapy for thyroid cancer Radioiodine therapy ≥150 mCi Age 18 or older 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 (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia) Nasolacrimal duct obstruction at baseline

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm (Artificial Tears)<br>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) | Drug: Artificial Tears Methylcellulose<br>* Participants will self-administer the artificial tears according to the schedule.<br>|
| No Intervention: No Intervention (No Artificial Tears)<br>Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO) | The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasolacrimal Duct Obstruction, Artificial Tears, Thyroid Cancer