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

NCT ID: NCT05999630

Last Updated: 2025-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nasolacrimal Duct Obstruction Thyroid Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Artificial Tears Methylcellulose

Intervention Type DRUG

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

No Intervention (No Artificial Tears)

Participants in this arm will not administer artificial tears in the 4 days immediately following radioactive iodine therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Artificial Tears Methylcellulose

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rachel Sobel

Associate Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marybeth Carter

Role: CONTACT

615-936-1639

Facility Contacts

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Rachel Sobel, MD

Role: primary

4152796578

Marybeth Carter

Role: backup

615-936-1639

Other Identifiers

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230845

Identifier Type: -

Identifier Source: org_study_id

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