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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | Patients with moderate to severe thyroid-associated ophthalmopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Break up time (BUT) | 13 weeks | |
| Visual acuity | 13 weeks | |
| Tear film osmolarity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Garhoefer, MD | Department of Clinical Pharmacology, Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D049970 | Graves Ophthalmopathy |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D006111 | Graves Disease |
| D005094 | Exophthalmos |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Esomeprazole | Drug | 40mg i.v. infusion once a week for 12 weeks |
|
| 13 weeks |
| Degree of exophthalmia | Hertel exophthalmometry | 13 weeks |
| Palpebral fissure width | 13 weeks |
| OSI (Objective Scattering Index) | 13 weeks |
| Tear cytokines/chemokines | 13 weeks |
| Impression cytology | 13 weeks |
| Staining of the cornea with fluorescein | 13 weeks |
| Schirmer I test | 13 weeks |
| Subjective symptoms of dry eye syndrome | 13 weeks |
| D009916 |
| Orbital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |