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

Overview

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.

Full Title of Study: “Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System of Patients Following Radioiodine Therapy for Thyroid Carcinoma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 25, 2023

Detailed Description

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Preservative free artificial tears
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Level of Radioactive Iodine in Tears
    • Time Frame: Over a 4 day period
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt-Ingram Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rachel Sobel, Principal Investigator – Vanderbilt-Ingram Cancer Center
  • Overall Official(s)
    • Rachel Sobel, MD, Principal Investigator, Vanderbilt Medical Center

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