Thyroid-associated ophthalmopathy (TAO), also called Graves' ophthalmopathy or thyroid eye disease, is a common orbital disease in adults. Patients with TAO, especially in its active phase, often complain about symptoms of ocular surface discomfort, including excess tearing, gritty sensation, increased sensitivity to light and foreign-body sensation, which are similar to inflammatory ocular surface disorders such as dry-eye syndrome (DES). Incomplete blink, increased proptosis and greater palpebral fissure width in TAO accelerates tear evaporation, which increases the tear fluid's osmolarity, and results in ocular surface damage. The administration of intravenous glucocorticoids can be an effective treatment for TAO. The rationale of the present study is to assess the effect of intravenously administered glucocorticoids on the signs of DES in patients with TAO with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film and well established methods for assessment of the severity of DES. Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
40mg i.v. infusion once a week for 12 weeks
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria
Tear film thickness as measured with OCT
Measurements of tear film thickness with OCT will be performed 7 or less days before start of treatment, 6 weeks after start of treatment and 12 weeks after start of treatment
Time frame: 13 weeks
Break up time (BUT)
Time frame: 13 weeks
Visual acuity
Time frame: 13 weeks
Tear film osmolarity
Time frame: 13 weeks
Degree of exophthalmia
Hertel exophthalmometry
Time frame: 13 weeks
Palpebral fissure width
Time frame: 13 weeks
OSI (Objective Scattering Index)
Time frame: 13 weeks
Tear cytokines/chemokines
Time frame: 13 weeks
Impression cytology
Time frame: 13 weeks
Staining of the cornea with fluorescein
Time frame: 13 weeks
Schirmer I test
Time frame: 13 weeks
Subjective symptoms of dry eye syndrome
Time frame: 13 weeks
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