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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05999630

Enrollment

100

Registered

2023-08-21

Start date

2023-08-21

Completion date

2027-12-31

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolacrimal Duct Obstruction, Thyroid Cancer

Keywords

Nasolacrimal Duct Obstruction, Artificial Tears, Thyroid Cancer

Brief 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.

Interventions

DRUGArtificial Tears Methylcellulose

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Radio-iodine therapy for thyroid cancer 2. Radioiodine therapy ≥150 mCi 3. Age 18 or older

Exclusion criteria

1. Use of eye drops, other than artificial tears 2. History of periocular trauma with tear duct involvement/lacrimal gland trauma 3. History of lacrimal drainage disease: canaliculitis, dacryocystitis 4. Prior radiotherapy 5. Current or prior use of chemotherapy drugs (i.e. 5-fluorouracil, docetaxel) 6. Medical conditions that predispose to NLD stenosis (i.e. sarcoidosis, granulomatosis with polyangiitis, chronic lymphocytic leukemia) 7. Nasolacrimal duct obstruction at baseline

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Post-Radiotherapy Nasolacrimal Duct Obstruction (NLDO)	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.

Countries

United States

Contacts

Primary ContactMarybeth Carter

marybeth.l.carter@vumc.org615-936-1639

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026