Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma
|ClinicalTrials.gov Identifier: NCT01579344|
Recruitment Status : Unknown
Verified April 2012 by Fabricio Lopes da Fonseca, University of Sao Paulo.
Recruitment status was: Enrolling by invitation
First Posted : April 17, 2012
Last Update Posted : April 18, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lacrimal Apparatus Disease||Drug: Radioiodine therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||March 2014|
Active Comparator: Thyroid carcinoma, Radioactive iodine therapy
50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma undergoing radioactive iodine therapy
Drug: Radioiodine therapy
Radioiodine therapy with NaI131
No Intervention: Thyroid carcinoma, without radioactive iodine therapy
50 patients (100 eyes) diagnosed with differentiated thyroid carcinoma not undergone radioactive iodine therapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579344
|University of Sao Paulo; Ophthalmology Department|
|São Paulo, SP, Brazil, 05403000|
|Principal Investigator:||Suzana Matayoshi, Professor||University of Sao Paulo|