Wounds and Injuries

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Neoplasms

Gland and Hormone Related Diseases

Eye Diseases

Rupture

Thyroid Neoplasms

Thyroid Diseases

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Lacrimal Duct Obstruction

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Lacrimal Apparatus Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Micronutrients

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Lubricant Eye Drops

Iodine

Cadexomer iodine

Ophthalmic Solutions

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)

Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.

Participants will self-administer the artificial tears according to the schedule.

Artificial Tears Methylcellulose

Marybeth Carter

Rachel Sobel, MD

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.

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

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

The rate of patients that developed NLDO after radioactive iodine therapy in each experimental group as determined by tear duct irrigation by an ophthalmologist.

Vanderbilt University Medical Center

Associate Professor of Ophthalmology

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

Self-Administered - utilizing eye drop preservative free vials

Artificial Tears

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.

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.

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

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

The radioactive iodine activity level in the tears will be measured, as collected via contact lenses. Each patient will have a control eye and an experimental eye that received artificial tears. The control eye has no intervention. The radioactive iodine activity level will be measured over four days, with Day 1 occurring on the Day of systemic radioactive iodine therapy. On each of the four days, the level of radioactive iodine will be compared between the control and experimental eyes to see if there is a statistical difference between the control and experimental eyes.

Vanderbilt-Ingram Cancer Center

Principal Investigator

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.

Artificial Tears: Self-Administered - utilizing eye drop preservative free vials

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer	NCT05999630	Nasolacrimal Du... Thyroid Cancer	Artificial Tear...	18 Years -	Vanderbilt University Medical Center
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System	NCT04327999	Thyroid Carcino... Radioactive Iod...	Artificial Tear...	18 Years -	Vanderbilt-Ingram Cancer Center

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