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Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01579344
Enrollment
100
Registered
2012-04-17
Start date
2012-01-31
Completion date
Unknown
Last updated
2012-04-18

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

Conditions

Lacrimal Apparatus Disease

Keywords

Iodine Radioisotopes, Nasolacrimal Duct, radiation effects

Brief summary

The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature. Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients. It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.

Interventions

DRUGRadioiodine therapy

Radioiodine therapy with NaI131

Sponsors

Fabricio Lopes da Fonseca
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Thyroid carcinoma * Previous thyroidectomy

Exclusion criteria

* Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic) * Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL * Lacrimal gland / ocular trauma * Radiation therapy for other diseases or radiotherapy of head and neck * Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.

Countries

Brazil

Outcome results

None listed

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