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NCT Number: NCT05999630

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

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.

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Key information

Conditions

Nasolacrimal Duct Obstruction Endocrine Gland Neoplasms Endocrine System Diseases Eye Diseases Head and Neck Neoplasms Lacrimal Apparatus Diseases Lacrimal Duct Obstruction Neoplasms Neoplasms by Site Thyroid Cancer Thyroid Diseases Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial Tears Methylcellulose

Drug

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

Primary outcomes

  1. Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Marybeth Carter

CONTACT

[email protected]

615-936-1639

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 21, 2023
Registry last updated
Oct 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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