Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Treated With Radioactive Iodine for Thyroid Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Tears Methylcellulose.
- Who it may be relevant to
- Registry conditions: Nasolacrimal Duct Obstruction, Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Use of Artificial Tears to Prevent Nasolacrimal Duct Obstruction in Patients Who Are Treated With Radioactive Iodine for Thyroid Cancer
Overview
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.
Interventions
- Drug Artificial Tears Methylcellulose
Participants will self-administer the artificial tears according to the schedule.
Primary outcome measures
- Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO) [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT05999630 · 230845