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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Radio-iodine therapy for thyroid cancer

Radioiodine therapy ≥150 mCi

Age 18 or older

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial Tears Methylcellulose

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental Arm (Artificial Tears)Experimental treatment 1 intervention
Group B: No Intervention (No Artificial Tears)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)

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

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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