The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated with Radioactive Iodine for Thyroid Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Radio-iodine therapy for thyroid cancer
• Radioiodine therapy ≥150 mCi
• Age 18 or older
Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Marybeth Carter
marybeth.l.carter@vumc.org
615-936-1639
Time Frame
Start Date:2023-08-21
Estimated Completion Date:2027-12-31
Participants
Target number of participants:100
Treatments
Experimental: 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)
No_intervention: No Intervention (No Artificial Tears)
Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.